Purpose

This phase II trial studies how well lower-dose chemotherapy plus radiation (chemoradiation) therapy works in comparison to standard-dose chemoradiation in treating patients with early-stage anal cancer. Drugs used in chemotherapy, such as mitomycin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving chemotherapy with radiation therapy may kill more tumor cells. This study may help doctors find out if lower-dose chemoradiation is as effective and has fewer side effects than standard-dose chemoradiation, which is the usual approach for treatment of this cancer type.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


Inclusion Criteria:

- Patient must have histologically proven T1-2N0M0 invasive anal canal or anal margin
squamous cell carcinoma with tumors measuring =< 4 cm within 4 weeks prior to
randomization. This may include tumors of non-keratinizing histology such as basaloid,
transitional cell or cloacogenic histology. Patients with T1N0M0 anal margin squamous
cell carcinoma who underwent surgical excision with negative margins are not eligible

- Patients who are human immunodeficiency virus (HIV)-negative must not have lymph nodes
that are radiographically-concerning for cancer involvement using computed tomography
(CT) and positron emission tomography (PET)/CT-based criteria. Measurable disease is
not required

- Patients who are HIV-negative and do not have lymph nodes classified as lymph
node positive, but are felt to be borderline for cancer involvement must undergo
central imaging review

- NOTE: Patients requiring central imaging review will be pre-registered to
Arm S. Upon central confirmation of no lymph node involvement, eligible
patients may proceed to randomization on Step 1

- Patients will be considered to be lymph node (LN) positive and thereby not
eligible in this study if the lymph nodes meet any of the following criteria:

- Mesorectal, presacral, internal iliac or obturator LN with:

- Short axis measuring > 5 mm based on CT / magnetic resonance imaging
(MRI) OR

- Morphologic features of irregular border or central necrosis if
assessed on MRI and LN measures > 3 mm OR

- Fludeoxyglucose F-18 (FDG) uptake > blood pool (Deauville 3-5) based on
PET/CT

- External Iliac and common Iliac:

- Short-axis measuring > 1 cm based on CT / MRI OR

- Morphologic features of irregular border or central necrosis based on
CT / MRI OR

- FDG uptake > blood pool (Deauville 3-5) based on PET/CT

- Inguinal LN (superficial and deep) meeting any of the following criteria will be
ineligible unless an FNA is performed and resulting cytology is negative.

- Morphologic features of irregular border or central necrosis based on CT /
MRI

- FDG uptake > liver (Deauville 4) based on PET/CT.

- Patients who are HIV-negative and have inguinal lymph nodes that do not meet
the above criteria must undergo fine needle aspiration and have negative
histology to be eligible.

- Patients who are HIV-positive must have

- A CD4 count >= 300

- Confirmation of no lymph node involvement by central real-time review of imaging

- NOTE: Patients will be pre-registered to Arm S. Upon central confirmation of
no lymph node involvement, eligible patients may proceed to randomization on
Step 1

- Patient must have Eastern Cooperative Oncology Group (ECOG) - American College of
Radiology Imaging Network (ACRIN) performance status of 0-2

- Patient must have no history of prior radiation or chemotherapy for this malignancy

- Patient must not have had prior potentially curative surgery (i.e. abdominal-perineal
resection) for carcinoma of the anus

- Patients with excisional biopsy procedure are eligible provided there was tumor
involvement of the anal canal and/or anal verge prior to resection

- Patient must not be receiving any other standard anti-cancer therapy or experimental
agent concurrently with the study drugs

- Patient must not have intercurrent illness including, but not limited to, ongoing or
active infection or psychiatric/social situations that, in the judgement of the
investigator, would limit compliance with study requirements

- Patient must not have had significant cardiovascular disease including myocardial
infarction, unstable angina, stroke, transient ischemic attack, symptomatic coronary
artery disease, symptomatic congestive heart failure, or uncontrolled cardiac
arrhythmia within 6 months of randomization

- Patient must not have a history of a different malignancy unless they have been
disease-free for at least 2 years and are deemed by the investigator to be at low risk
of recurrence

- Individuals with the following cancers are eligible if diagnosed and treated
within the past 5 years: cervical cancer in situ and basal cell or squamous cell
carcinoma of the skin

- Patient must not have active autoimmune or connective disease

- Patients who are on anti-coagulation with warfarin within 2 weeks prior to
registration and are considering the use of capecitabine, must use an alternative
anti-coagulant

- NOTE: Low molecular weight heparin is permitted provided the patient's
prothrombin time (PT)/international normalized ratio (INR) is < 1.5

- Patients who will receive capecitabine and are on Dilantin for a seizure disorder must
have Dilantin levels checked weekly

- Hemoglobin > 10 g/dL (within 2 weeks prior to registration)

- Platelets >= 100,000/mm^3 (within 2 weeks prior to registration)

- Absolute neutrophil count >= 1500/mm^3 (within 2 weeks prior to registration)

- Serum creatinine must be < 1.5 X upper limit of normal (ULN), or calculated creatinine
clearance must be > 60 ml/min (within 2 weeks prior to registration)

- Total bilirubin must be < 2 X ULN (within 2 weeks prior to registration)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 X institutional
ULN (within 2 weeks prior to registration)

- Albumin >= 3.0 g/dL (within 2 weeks prior to registration)

- Women must not be pregnant or breast-feeding because the study treatment administered
may cause harm to an unborn fetus or breastfeeding child. All females of childbearing
potential must have a blood test or urine study within 2 weeks prior to registration
to rule out pregnancy. A female of childbearing potential is any woman, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not undergone a
hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal
(amenorrhea following cancer therapy does not rule out childbearing potential) for at
least 24 consecutive months (i.e., has had menses at any time in the preceding 24
consecutive months)

- Women of childbearing potential and sexually active males must be strongly advised to
use accepted and effective method(s) of contraception or to abstain from sexual
intercourse for the duration of their participation in the study and for at least 6
months after the completion of treatment

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm A (standard-dose chemoradiation)
Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.
  • Drug: Capecitabine
    Given PO
    Other names:
    • Ro 09-1978/000
    • Xeloda
  • Drug: Fluorouracil
    Given IV
    Other names:
    • 5 Fluorouracil
    • 5 Fluorouracilum
    • 5 FU
    • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    • 5-Fluorouracil
    • 5-Fluracil
    • 5-FU
    • 5FU
    • AccuSite
    • Carac
    • Fluoro Uracil
    • Fluouracil
    • Flurablastin
    • Fluracedyl
    • Fluracil
    • Fluril
    • Fluroblastin
    • Ribofluor
    • Ro 2-9757
    • Ro-2-9757
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other names:
    • IMRT
    • Intensity Modulated RT
    • Intensity-Modulated Radiotherapy
  • Drug: Mitomycin
    Given IV
    Other names:
    • Ametycine
    • MITO
    • MITO-C
    • Mito-Medac
    • Mitocin
    • Mitocin-C
    • Mitolem
    • Mitomycin C
    • Mitomycin-C
    • Mitomycin-X
    • Mitomycine C
    • Mitosol
    • Mitozytrex
    • Mutamycin
    • Mutamycine
    • NCI-C04706
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Experimental
Arm B (de-intensified chemoradiation)
Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity.
  • Drug: Capecitabine
    Given PO
    Other names:
    • Ro 09-1978/000
    • Xeloda
  • Drug: Fluorouracil
    Given IV
    Other names:
    • 5 Fluorouracil
    • 5 Fluorouracilum
    • 5 FU
    • 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    • 5-Fluorouracil
    • 5-Fluracil
    • 5-FU
    • 5FU
    • AccuSite
    • Carac
    • Fluoro Uracil
    • Fluouracil
    • Flurablastin
    • Fluracedyl
    • Fluracil
    • Fluril
    • Fluroblastin
    • Ribofluor
    • Ro 2-9757
    • Ro-2-9757
  • Radiation: Intensity-Modulated Radiation Therapy
    Undergo IMRT
    Other names:
    • IMRT
    • Intensity Modulated RT
    • Intensity-Modulated Radiotherapy
  • Drug: Mitomycin
    Given IV
    Other names:
    • Ametycine
    • MITO
    • MITO-C
    • Mito-Medac
    • Mitocin
    • Mitocin-C
    • Mitolem
    • Mitomycin C
    • Mitomycin-C
    • Mitomycin-X
    • Mitomycine C
    • Mitosol
    • Mitozytrex
    • Mutamycin
    • Mutamycine
    • NCI-C04706
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Alaska Women's Cancer Care
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Anchorage Oncology Centre
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
Anchorage, Alaska 99508
Contact:
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org

Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373

CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Site Public Contact
501-686-8274

PCR Oncology
Arroyo Grande, California 93420
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Contact:
Site Public Contact
818-847-4793
Najee.Boucher@providence.org

UC San Diego Moores Cancer Center
La Jolla, California 92093
Contact:
Site Public Contact
858-822-5354
cancercto@ucsd.edu

UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
Contact:
Site Public Contact
650-498-7061
ccto-office@stanford.edu

Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401
Contact:
Site Public Contact
Diane.DeVos-Schmidt@DignityHealth.org

Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444
Contact:
Site Public Contact
916-851-2283
research@dignityhealth.org

Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
303-777-2663
info@westernstatesncorp.org

Porter Adventist Hospital
Denver, Colorado 80210
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Saint Anthony Hospital
Lakewood, Colorado 80228
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Littleton Adventist Hospital
Littleton, Colorado 80122
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Longmont United Hospital
Longmont, Colorado 80501
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Parker Adventist Hospital
Parker, Colorado 80138
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Saint Mary Corwin Medical Center
Pueblo, Colorado 81004
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Beebe South Coastal Health Campus
Frankford, Delaware 19945
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

Beebe Medical Center
Lewes, Delaware 19958
Contact:
Site Public Contact
302-645-3770
Dmiskin@Beebehealthcare.org

Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

Helen F Graham Cancer Center
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718
Contact:
Site Public Contact
302-623-4450
mhayden@christianacare.org

Beebe Health Campus
Rehoboth Beach, Delaware 19971
Contact:
Site Public Contact
302-645-3100
Dmiskin@Beebehealthcare.org

TidalHealth Nanticoke / Allen Cancer Center
Seaford, Delaware 19973
Contact:
Site Public Contact
410-543-7019
anna-maria.howard@peninsula.org

UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida 33146
Contact:
Site Public Contact
305-243-2647

UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida 33442
Contact:
Site Public Contact
305-243-2647

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida 33136
Contact:
Site Public Contact
305-243-2647

Miami Cancer Institute
Miami, Florida 33176
Contact:
Site Public Contact
786-596-2000

Orlando Health Cancer Institute
Orlando, Florida 32806
Contact:
Site Public Contact
321-841-7246
CancerClinicalTrials@orlandohealth.com

Cleveland Clinic-Weston
Weston, Florida 33331
Contact:
Site Public Contact
954-659-5705
CancerAnswer@ccf.org

Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
734-712-3671
stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Saint Alphonsus Medical Center-Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Contact:
Site Public Contact
208-381-2774
eslinget@slhs.org

Rush - Copley Medical Center
Aurora, Illinois 60504
Contact:
Site Public Contact
630-978-6212
Cancer.Research@rushcopley.com

Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton, Illinois 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Contact:
Site Public Contact
618-457-5200
clinical.research@sih.net

SIH Cancer Institute
Carterville, Illinois 62918
Contact:
Site Public Contact
618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage, Illinois 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia, Illinois 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Northwestern University
Chicago, Illinois 60611
Contact:
Site Public Contact
312-695-1301
cancer@northwestern.edu

University of Illinois
Chicago, Illinois 60612
Contact:
Site Public Contact
312-355-3046

Carle on Vermilion
Danville, Illinois 61832
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Carle Physician Group-Effingham
Effingham, Illinois 62401
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Eureka
Eureka, Illinois 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831

Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb, Illinois 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Site Public Contact
708-226-4357

Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600

Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Peoria, Illinois 61636
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

OSF Saint Francis Medical Center
Peoria, Illinois 61637
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru, Illinois 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Valley Radiation Oncology
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141

Illinois CancerCare-Princeton
Princeton, Illinois 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Southern Illinois University School of Medicine
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929

Springfield Clinic
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541

Memorial Medical Center
Springfield, Illinois 62781
Contact:
Site Public Contact
217-788-3528

Carle Cancer Center
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

The Carle Foundation Hospital
Urbana, Illinois 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Illinois CancerCare - Washington
Washington, Illinois 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Reid Health
Richmond, Indiana 47374
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Mary Greeley Medical Center
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132

McFarland Clinic PC - Ames
Ames, Iowa 50010
Contact:
Site Public Contact
515-239-4734
ksoder@mcfarlandclinic.com

Saint Anthony Regional Hospital
Carroll, Iowa 51401
Contact:
Site Public Contact
515-689-7658
sbenson@iora.org

Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa 52402
Contact:
Site Public Contact
319-297-2900

Saint Luke's Hospital
Cedar Rapids, Iowa 52402
Contact:
Site Public Contact
319-368-5514
Rachel.varner@unitypoint.org

Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Iowa Methodist Medical Center
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727

Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-282-2921

Broadlawns Medical Center
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200

Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Iowa Lutheran Hospital
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704

Methodist West Hospital
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

University of Kansas Clinical Research Center
Fairway, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Lawrence Memorial Hospital
Lawrence, Kansas 66044
Contact:
Site Public Contact
785-505-2800
Stephanie.Norris@LMH.ORG

Olathe Health Cancer Center
Olathe, Kansas 66061
Contact:
Site Public Contact
913-355-8000
Jeni.wakefield@olathehealth.org

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Ascension Via Christi - Pittsburg
Pittsburg, Kansas 66762
Contact:
Site Public Contact
620-235-7900
jennifer.jameson@ascension.org

Salina Regional Health Center
Salina, Kansas 67401
Contact:
Site Public Contact
785-452-7038
mleepers@srhc.com

University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
Contact:
Site Public Contact
785-295-8000

University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Saint Joseph Radiation Oncology Resource Center
Lexington, Kentucky 40504
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Saint Joseph Hospital East
Lexington, Kentucky 40509
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Jewish Hospital
Louisville, Kentucky 40202
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Jewish Hospital Medical Center Northeast
Louisville, Kentucky 40245
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
Contact:
Site Public Contact
504-703-8712
Gregory.Johnstone@ochsner.org

MaineHealth Coastal Cancer Treatment Center
Bath, Maine 04530
Contact:
Site Public Contact
888-823-5923
ctsucontact@westat.com

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford
Biddeford, Maine 04005
Contact:
Site Public Contact
LLemire@mmc.org

LincolnHealth - Miles Campus and Hospital
Damariscotta, Maine 04543
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

Maine Medical Center-Bramhall Campus
Portland, Maine 04102
Contact:
Site Public Contact
207-885-7565

Penobscot Bay Medical Center
Rockport, Maine 04856
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

MaineHealth Cancer Care Center of York County
Sanford, Maine 04073
Contact:
Site Public Contact
207-459-1600

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford
Sanford, Maine 04073
Contact:
Site Public Contact
LLemire@mmc.org

Maine Medical Center- Scarborough Campus
Scarborough, Maine 04074
Contact:
Site Public Contact
207-396-8090
wrighd@mmc.org

Maine Medical Partners - South Portland
South Portland, Maine 04106
Contact:
Site Public Contact
207-396-8670
ClinicalResearch@mmc.org

Greater Baltimore Medical Center
Baltimore, Maryland 21204
Contact:
Site Public Contact
443-849-3706

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Site Public Contact
617-638-8265

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Contact:
Site Public Contact
617-667-9925

University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125

Bronson Battle Creek
Battle Creek, Michigan 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

McLaren Cancer Institute-Bay City
Bay City, Michigan 48706
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125

McLaren Cancer Institute-Clarkston
Clarkston, Michigan 48346
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Flint
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Singh and Arora Hematology Oncology PC
Flint, Michigan 48532
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Mercy Health Saint Mary's
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Borgess Medical Center
Kalamazoo, Michigan 49048
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

McLaren-Greater Lansing
Lansing, Michigan 48910
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Mid-Michigan Physicians-Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Lapeer Region
Lapeer, Michigan 48446
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren Cancer Institute-Macomb
Mount Clemens, Michigan 48043
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Mercy Health Mercy Campus
Muskegon, Michigan 49444
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Lakeland Hospital Niles
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230

Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Contact:
Site Public Contact
616-391-1230
connie.szczepanek@crcwm.org

McLaren Cancer Institute-Northern Michigan
Petoskey, Michigan 49770
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

McLaren-Port Huron
Port Huron, Michigan 48060
Contact:
Site Public Contact
313-576-9790
ctoadmin@karmanos.org

Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Munson Medical Center
Traverse City, Michigan 49684
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Metro Health Hospital
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
Contact:
Site Public Contact
218-333-5000
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Fairview Ridges Hospital
Burnsville, Minnesota 55337
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mercy Hospital
Coon Rapids, Minnesota 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Cancer Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health Saint Mary's Medical Center
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Miller-Dwan Hospital
Duluth, Minnesota 55805
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Fairview Southdale Hospital
Edina, Minnesota 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota 56537
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Essentia Health - Fosston
Fosston, Minnesota 56542
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Unity Hospital
Fridley, Minnesota 55432
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
Contact:
Site Public Contact
218-786-3308

Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Health Partners Inc
Minneapolis, Minnesota 55454
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Monticello Cancer Center
Monticello, Minnesota 55362
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health - Park Rapids
Park Rapids, Minnesota 56470
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul, Minnesota 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul, Minnesota 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Sandstone
Sandstone, Minnesota 55072
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Lakeview Hospital
Stillwater, Minnesota 55082
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Essentia Health Virginia Clinic
Virginia, Minnesota 55792
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Ridgeview Medical Center
Waconia, Minnesota 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Rice Memorial Hospital
Willmar, Minnesota 56201
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058

Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-334-2230
sfmc@sfmc.net

Southeast Cancer Center
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550

Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Parkland Health Center - Farmington
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569

Capital Region Southwest Campus
Jefferson City, Missouri 65109
Contact:
Site Public Contact
573-632-4814
swooden@mail.crmc.org

Freeman Health System
Joplin, Missouri 64804
Contact:
Site Public Contact
417-347-4030
LJCrockett@freemanhealth.com

Mercy Hospital Joplin
Joplin, Missouri 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

University of Kansas Cancer Center - North
Kansas City, Missouri 64154
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri 64116
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-7504
research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379

Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Contact:
Site Public Contact
816-271-7937
linda.schumacher@mymlc.com

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital South
Saint Louis, Missouri 63128
Contact:
Site Public Contact
janet.lesko@mercy.net

Siteman Cancer Center-South County
Saint Louis, Missouri 63129
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Missouri Baptist Medical Center
Saint Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569

Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066

Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
Contact:
Site Public Contact
800-600-3606
info@siteman.wustl.edu

Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520

CoxHealth South Hospital
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520

Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569

Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569

Billings Clinic Cancer Center
Billings, Montana 59101
Contact:
Site Public Contact
800-996-2663
research@billingsclinic.org

Bozeman Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Great Falls Clinic
Great Falls, Montana 59405
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Kalispell Regional Medical Center
Kalispell, Montana 59901
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

Community Medical Hospital
Missoula, Montana 59804
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

CHI Health Saint Francis
Grand Island, Nebraska 68803
Contact:
Site Public Contact
308-398-5450

CHI Health Good Samaritan
Kearney, Nebraska 68847
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Nebraska Methodist Hospital
Omaha, Nebraska 68114
Contact:
Site Public Contact
402-354-5144

Alegent Health Immanuel Medical Center
Omaha, Nebraska 68122
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska 68124
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Alegent Health Lakeside Hospital
Omaha, Nebraska 68130
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Creighton University Medical Center
Omaha, Nebraska 68131
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

21st Century Oncology
Las Vegas, Nevada 89109
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Renown Regional Medical Center
Reno, Nevada 89502
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Saint Mary's Regional Medical Center
Reno, Nevada 89503
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Radiation Oncology Associates
Reno, Nevada 89509
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@dartmouth.edu

Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
Contact:
Site Public Contact
212-639-7592

Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
Contact:
Site Public Contact
212-639-7592

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
Contact:
Site Public Contact
732-235-7356

Rutgers New Jersey Medical School
Newark, New Jersey 07101
Contact:
Site Public Contact
732-235-7356

Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-272-0530
AYost@nmcca.org

University of New Mexico Cancer Center
Albuquerque, New Mexico 87102
Contact:
Site Public Contact
505-925-0366
LByatt@nmcca.org

Lovelace Radiation Oncology
Albuquerque, New Mexico 87109
Contact:
Site Public Contact
505-272-0530
AYost@nmcca.org

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
eskwak@montefiore.org

Sands Cancer Center
Canandaigua, New York 14424
Contact:
Site Public Contact
585-396-6161

Memorial Sloan Kettering Commack
Commack, New York 11725
Contact:
Site Public Contact
212-639-7592

Mary Imogene Bassett Hospital
Cooperstown, New York 13326
Contact:
Site Public Contact
877-547-1750
CancerClinicalTrials@bassett.org

Memorial Sloan Kettering Westchester
Harrison, New York 10604
Contact:
Site Public Contact
212-639-7592

Mount Sinai Union Square
New York, New York 10003
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai Chelsea
New York, New York 10011
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai West
New York, New York 10019
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

Mount Sinai Hospital
New York, New York 10029
Contact:
Site Public Contact
212-824-7309
CCTO@mssm.edu

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
Contact:
Site Public Contact
212-305-6361
nr2616@cumc.columbia.edu

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Site Public Contact
212-639-7592

Wilmot Cancer Institute Radiation Oncology at Greece
Rochester, New York 14606
Contact:
Site Public Contact
585-758-7877

Highland Hospital
Rochester, New York 14620
Contact:
Site Public Contact
585-341-8113

University of Rochester
Rochester, New York 14642
Contact:
Site Public Contact
585-275-5830

Memorial Sloan Kettering Nassau
Uniondale, New York 11553
Contact:
Site Public Contact
212-639-7592

Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Sanford Broadway Medical Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-323-5760
OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161
OncologyClinicalTrialsFargo@sanfordhealth.org

Essentia Health - Jamestown Clinic
Jamestown, North Dakota 58401
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital South
Centerville, Ohio 45459
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Geauga Hospital
Chardon, Ohio 44024
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-584-7698
cancer@uchealth.com

Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio 45220
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Bethesda North Hospital
Cincinnati, Ohio 45242
Contact:
Site Public Contact
308-398-6518
clinicaltrials@sfmc-gi.org

Case Western Reserve University
Cleveland, Ohio 44106
Contact:
Site Public Contact
800-641-2422
CTUReferral@UHhospitals.org

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-8526
dstrater@metrohealth.org

Cleveland Clinic Foundation
Cleveland, Ohio 44195
Contact:
Site Public Contact
866-223-8100
TaussigResearch@ccf.org

Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Contact:
Site Public Contact
800-293-5066
Jamesline@osumc.edu

Miami Valley Hospital
Dayton, Ohio 45409
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
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Miami Valley Hospital North
Dayton, Ohio 45415
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Mercy Cancer Center-Elyria
Elyria, Ohio 44035
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800-641-2422
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Armes Family Cancer Center
Findlay, Ohio 45840
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Blanchard Valley Hospital
Findlay, Ohio 45840
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Orion Cancer Care
Findlay, Ohio 45840
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Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
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Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
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937-528-2900
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Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
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Wayne Hospital
Greenville, Ohio 45331
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Greater Dayton Cancer Center
Kettering, Ohio 45409
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Kettering Medical Center
Kettering, Ohio 45429
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UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio 44060
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800-641-2422
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UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
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University Hospitals Parma Medical Center
Parma, Ohio 44129
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800-641-2422
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University Hospitals Portage Medical Center
Ravenna, Ohio 44266
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800-641-2422
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UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
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800-641-2422
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Springfield Regional Cancer Center
Springfield, Ohio 45504
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Springfield Regional Medical Center
Springfield, Ohio 45505
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Dayton Physicians LLC-Upper Valley
Troy, Ohio 45373
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Upper Valley Medical Center
Troy, Ohio 45373
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Saint Joseph Warren Hospital
Warren, Ohio 44484
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University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
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513-584-7698
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UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
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UHHS-Westlake Medical Center
Westlake, Ohio 44145
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Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
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Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
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877-231-4440

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
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405-271-8777
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Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
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405-752-3402

Saint Charles Health System
Bend, Oregon 97701
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541-706-2909
nosall@stcharleshealthcare.org

Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
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503-215-2614
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Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
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503-215-2614
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Bay Area Hospital
Coos Bay, Oregon 97420
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541-269-8392
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Providence Newberg Medical Center
Newberg, Oregon 97132
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Providence Portland Medical Center
Portland, Oregon 97213
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503-215-2614
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Providence Saint Vincent Medical Center
Portland, Oregon 97225
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503-215-2614
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Oregon Health and Science University
Portland, Oregon 97239
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503-494-1080
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Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
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302-623-4450
mhayden@christianacare.org

Geisinger Medical Center
Danville, Pennsylvania 17822
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570-271-5251
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Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
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570-374-8555
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Lewistown Hospital
Lewistown, Pennsylvania 17044
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717-242-7703
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Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
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800-275-6401
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Reading Hospital
West Reading, Pennsylvania 19611
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610-988-9323

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
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570-271-5251
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AnMed Health Cancer Center
Anderson, South Carolina 29621
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864-512-4651
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Saint Francis Hospital
Greenville, South Carolina 29601
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864-603-6213
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Saint Francis Cancer Center
Greenville, South Carolina 29607
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864-603-6213
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Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
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605-312-3320
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Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
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Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
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800-811-8480

Saint Joseph Regional Cancer Center
Bryan, Texas 77802
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308-398-6518
clinicaltrials@sfmc-gi.org

MD Anderson in The Woodlands
Conroe, Texas 77384
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866-632-6789
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Parkland Memorial Hospital
Dallas, Texas 75235
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214-590-5582
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UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
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M D Anderson Cancer Center
Houston, Texas 77030
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MD Anderson West Houston
Houston, Texas 77079
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MD Anderson League City
League City, Texas 77573
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MD Anderson in Sugar Land
Sugar Land, Texas 77478
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Farmington Health Center
Farmington, Utah 84025
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University of Utah Sugarhouse Health Center
Salt Lake City, Utah 84106
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
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Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
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802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
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University of Vermont and State Agricultural College
Burlington, Vermont 05405
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Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
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802-473-4100

Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
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360-412-8958
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Overlake Medical Center
Bellevue, Washington 98004
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PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
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Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington 98310
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Harrison Medical Center
Bremerton, Washington 98310
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Highline Medical Center-Main Campus
Burien, Washington 98166
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Providence Regional Cancer System-Centralia
Centralia, Washington 98531
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Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
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206-215-3086
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Providence Regional Cancer Partnership
Everett, Washington 98201
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Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
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Providence Regional Cancer System-Lacey
Lacey, Washington 98503
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PeaceHealth Saint John Medical Center
Longview, Washington 98632
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Valley Medical Center
Renton, Washington 98055
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Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
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Swedish Medical Center-First Hill
Seattle, Washington 98122-4307
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PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
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PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
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Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
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509-897-5993
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North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington 98902
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509-574-3535
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ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
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920-364-3605
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Duluth Clinic Ashland
Ashland, Wisconsin 54806
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218-786-3308
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Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
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218-786-3308
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Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
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414-302-2304
ncorp@aurora.org

Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
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800-782-8581
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Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
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414-302-2304
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Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
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414-302-2304
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Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
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414-302-2304
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UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin 53038
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920-699-3500
lynda.persico@uwmf.wisc.edu

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
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414-302-2304
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University of Wisconsin Hospital and Clinics
Madison, Wisconsin 53792
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800-622-8922

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
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414-302-2304
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Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
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800-782-8581
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Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
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414-302-2304
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Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
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414-302-2304
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Medical College of Wisconsin
Milwaukee, Wisconsin 53226
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414-805-3666

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
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414-302-2304
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Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
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800-782-8581
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ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
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research.institute@phci.org

Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
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952-993-1517
mmcorc@healthpartners.com

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
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262-928-7878

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
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414-302-2304
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Aurora Cancer Care-Racine
Racine, Wisconsin 53406
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414-302-2304
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Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
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800-782-8581
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Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
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414-302-2304
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Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
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800-782-8581
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Aurora Medical Center in Summit
Summit, Wisconsin 53066
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414-302-2304
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Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
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414-302-2304
ncorp@aurora.org

UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
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262-928-5539
Chanda.miller@phci.org

Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin 53226
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414-302-2304
ncorp@aurora.org

Aurora West Allis Medical Center
West Allis, Wisconsin 53227
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414-302-2304
ncorp@aurora.org

Diagnostic and Treatment Center
Weston, Wisconsin 54476
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888-799-3989
oncology.clinical.trials@marshfieldresearch.org

Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Contact:
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800-782-8581
oncology.clinical.trials@marshfieldresearch.org

Welch Cancer Center
Sheridan, Wyoming 82801
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

More Details

NCT ID
NCT04166318
Status
Recruiting
Sponsor
ECOG-ACRIN Cancer Research Group

Detailed Description

PRIMARY OBJECTIVES: I. To determine whether de-intensified chemoradiation for early stage squamous cell carcinoma of the anal canal (SCCA) is able to maintain excellent 2-year disease control of 85% or higher while improving anorectal health-related quality of life (HRQL), compared to standard-dose chemoradiation therapy (CRT), as measured by the change in the Fecal Incontinence Quality of Life scale (FIQoL) instrument coping/behavior domain from baseline to 1 year. SECONDARY OBJECTIVES: I. To compare changes in patient-reported outcomes (as per Fecal Incontinence Severity Index [FISI], Patient Reported Outcomes Measurement Information System [PROMIS], International Index of Erectile Function [IIEF], Sexual Function-Vaginal Changes Questionnaire [SVQ], and Vaginal Assessment Scale [VAS]/Vulvar Assessment Scale [VuAS] instruments) between the experimental and control arm. II. To compare patterns of failure (local and regional relapse versus distant; in-field versus out-of-field of radiation), disease control, and overall survival between experimental and control arm. III. To correlate vaginal dilator use during radiation delivery with sexual function. IV. To measure changes in serum total testosterone from baseline to up to 12 months after radiation. V. To validate the utility of image features of inguinal and pelvic lymph nodes obtained prior to treatment as a prognostic indicator that can identify patients with early-stage anal squamous cell carcinoma for whom treatment with de-intensified chemoradiation is appropriate. VI. To determine whether an online, interactive educational tool (eContour) may improve the quality of radiation target delineation for anal cancer. VII. To determine the incidence of and predictors for cardiovascular toxicity in patients receiving fluorouracil (5-FU) or capecitabine. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (STANDARD-DOSE CHEMORADIATION): Patients undergo 28 fractions of intensity-modulated radiation therapy (IMRT). Within 24 hours, patients also receive mitomycin intravenously (IV) over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 and 29-32 or capecitabine orally (PO) twice daily (BID) 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. ARM B (DE-INTENSIFIED CHEMORADIATION): Patients undergo 20 or 23 fractions of IMRT. Within 24 hours, patients also receive mitomycin IV over 30 minutes or less on day 1 and either fluorouracil IV over 24 hours on days 1-4 or capecitabine PO BID 5 days per week (Monday - Friday) until completion of IMRT in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 6 weeks, every 3 months for years 1-2, every 6 months for year 3, then annually for years 4-5.

Notice

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