Testing the Addition of the Chemotherapy Drug Lomustine (Gleostine®) to the Usual Treatment (Temozolomide and Radiation Therapy) for Newly Diagnosed MGMT Methylated Glioblastoma

Purpose

This phase III trial compares the effect of adding lomustine to temozolomide and radiation therapy versus temozolomide and radiation therapy alone in shrinking or stabilizing newly diagnosed MGMT methylated glioblastoma. Chemotherapy drugs, such as lomustine and temozolomide, 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 photons to kill tumor cells and shrink tumors. Adding lomustine to usual treatment of temozolomide and radiation therapy may help shrink and stabilize glioblastoma.

Conditions

  • Glioblastoma
  • Gliosarcoma

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • STEP 1 REGISTRATION: No known IDH mutation. (If tested before step 1 registration, patients known to have IDH mutation in the tumor on local or other testing are ineligible and should not be registered) - STEP 1 REGISTRATION: Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block and hematoxylin and eosin (H&E) stained slide to be sent for central pathology review for confirmation of histology and MGMT promoter methylation status. Note that tissue for central pathology review and central MGMT assessment must be received by the NYU Center for Biospecimen Research and Development (CBRD) on or before postoperative calendar day 30. If tissue cannot be received by postoperative calendar day 30, then patients may NOT enroll on this trial as central pathology review will not be complete in time for the patient to start treatment no later than 8 weeks following surgery. Results of central pathology review and central MGMT analysis will generally be conveyed to NRG Oncology within 10 business days of receipt of tissue. Note: In the event of an additional tumor resection(s), tissue must be received within 30 days of the most recent resection and the latest resection must have been performed within 30 days after the initial resection. Surgical resection is required; stereotactic biopsy alone is not allowed because it will not provide sufficient tissue for MGMT analysis - STEP 1 REGISTRATION: Contrast-enhanced brain MRI after surgery - STEP 1 REGISTRATION: Willing to use highly effective method of contraception for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 6 months after completing treatment; this inclusion is necessary because the treatment in this study may be significantly teratogenic - STEP 1 REGISTRATION: The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information - STEP 2 REGISTRATION: Histopathologically proven diagnosis of glioblastoma (or gliosarcoma as a subtype of glioblastoma) confirmed by central pathology review - STEP 2 REGISTRATION: MGMT promoter with methylation confirmed by central pathology review (See Section 10 for details). Note: Patients with tissue that is insufficient or inadequate for analysis, fails MGMT testing, or has indeterminate or unmethylated MGMT promoter are excluded. - STEP 2 REGISTRATION: IDH mutation testing by at least one method (such as immunohistochemistry for IDH1 R132H) must be performed as part of standard of care and no mutation must be found (i.e IDH wildtype). (If a mutation is identified then the patient will be ineligible and must be registered as ineligible at Step 2.) - STEP 2 REGISTRATION: History/physical examination within 28 days prior to Step 2 registration - STEP 2 REGISTRATION: Karnofsky performance status (KPS) >= 70 within 28 days prior to Step 2 registration - STEP 2 REGISTRATION: Neurologic function assessment within 28 days prior to Step 2 registration - STEP 2 REGISTRATION: Age 18-70 years Adequate hematologic, renal, and hepatic function within 14 days prior to STEP 2 REGISTRATION defined as follows: - STEP 2 REGISTRATION: Hemoglobin >= 10 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin (Hgb) >= 10.0 g/dl is acceptable) - STEP 2 REGISTRATION: Leukocytes >= 2,000/mm^3 - STEP 2 REGISTRATION: Absolute neutrophil count >= 1,500/mm^3 - STEP 2 REGISTRATION: Platelets >= 100,000/mm^3 - STEP 2 REGISTRATION: Total bilirubin =< 1.5 x institutional/lab upper limit of normal (ULN) - STEP 2 REGISTRATION: Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) =< 2.5 x ULN - STEP 2 REGISTRATION: Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x ULN - STEP 2 REGISTRATION: Serum creatinine =< 1.5 x ULN OR creatinine clearance (CrCl) >= 50 mL/min (if using the Cockcroft-Gault formula - STEP 2 REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated - Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B) - STEP 2 REGISTRATION: For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load - Note: Known positive test for hepatitis C virus ribonucleic acid (HCV ribonucleic acid [RNA]) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy - STEP 2 REGISTRATION: Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to step 2 registration are eligible for this trial. Testing is not required for entry into protocol - STEP 2 REGISTRATION: Negative serum or urine pregnancy test (in persons of childbearing potential) within 14 days prior to Step 2 registration - Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal

Exclusion Criteria

  • STEP 2 REGISTRATION: Prior therapy for tumor, except for resection or prior laser interstitial thermal therapy (LITT). For example, prior chemotherapy, immunotherapy, or targeted therapy for GBM or lower grade glioma is disallowed (including but not limited to temozolomide, lomustine, bevacizumab, any viral therapy, ipilimumab or other CTLA-4 antibody, PD-1 antibody, CD-137 agonist, CD40 antibody, PDL-1 or 2 antibody, vaccine therapy, polio or similar viral injection as treatment for the tumor, and/or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) as is Gliadel wafer, radiotherapy, radiosurgery, vaccine or other immunotherapy, brachytherapy, or convection enhanced delivery - Note: 5-aminolevulinic acid (ALA)-mediated fluorescent guided resection (FGR) photodynamic therapy (PDT) or fluorescein administered prior to/during surgery to aid resection is not exclusionary and is not considered a chemotherapy or intracerebral agent. Prior laser interstitial thermal therapy (LITT) is allowed. - STEP 2 REGISTRATION: Current or planned treatment with any other investigational agents for the study cancer - STEP 2 REGISTRATION: Definitive clinical or radiologic evidence of metastatic disease outside the brain - STEP 2 REGISTRATION: Prior invasive malignancy (except non-melanomatous skin cancer, cervical cancer in situ and melanoma in situ) unless disease free for a minimum of 2 years - STEP 2 REGISTRATION: Prior radiotherapy to the head or neck that would result in overlap of radiation therapy fields - STEP 2 REGISTRATION: Pregnancy and individuals unwilling to discontinue nursing due to the potential teratogenic effects and potential risk for adverse events in nursing infants - STEP 2 REGISTRATION: History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or lomustine - STEP 2 REGISTRATION: History of pulmonary fibrosis - STEP 2 REGISTRATION: Uncontrolled intercurrent illness including, but not limited to: - Ongoing or active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatment - Symptomatic congestive heart failure, defined as New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification) - Unstable angina pectoris within 6 months prior to Step 2 registration - Uncontrolled cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements - STEP 2 REGISTRATION: No evidence of diffuse leptomeningeal disease that requires whole brain irradiation.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Arm I (radiation therapy, temozolomide) 		Patients undergo radiation therapy 5 days per week and receive temozolomide PO QD for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
  • Radiation: Photon Beam Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Photon EBRT
    • Photon External Beam Radiotherapy
    • Radiation, Photon Beam
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Drug: Temozolomide
    Given PO
    Other names:
    • CCRG-81045
    • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
    • M & B 39831
    • M and B 39831
    • Methazolastone
    • RP-46161
    • SCH 52365
    • Temcad
    • Temodal
    • Temodar
    • Temomedac
    • TMZ
Experimental
ARM II (radiation therapy, temozolomide, lomustine) 		Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
  • Drug: Lomustine
    Given PO
    Other names:
    • 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea
    • 1-Nitrosourea, 1-(2-chloroethyl)-3-cyclohexyl-
    • Belustin
    • Belustine
    • CCNU
    • Cecenu
    • CeeNU
    • Chloroethylcyclohexylnitrosourea
    • Citostal
    • Gleostine
    • Lomeblastin
    • Lomustinum
    • Lucostin
    • Lucostine
    • N-(2-Chloroethyl)-N'-cyclohexyl-N-nitrosourea
    • Prava
    • RB-1509
    • WR-139017
  • Radiation: Photon Beam Radiation Therapy
    Undergo radiation therapy
    Other names:
    • Photon EBRT
    • Photon External Beam Radiotherapy
    • Radiation, Photon Beam
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
  • Drug: Temozolomide
    Given PO
    Other names:
    • CCRG-81045
    • Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
    • M & B 39831
    • M and B 39831
    • Methazolastone
    • RP-46161
    • SCH 52365
    • Temcad
    • Temodal
    • Temodar
    • Temomedac
    • TMZ

Recruiting Locations

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

Kaiser Permanente-Anaheim
Anaheim, California 92806
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Deer Valley Medical Center
Antioch, California 94531
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Auburn Faith Hospital
Auburn, California 95602
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California 95603
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Mercy Cancer Center - Carmichael
Carmichael, California 95608
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Mercy San Juan Medical Center
Carmichael, California 95608
Contact:
Site Public Contact
916-556-3301
OncologyResearch@DignityHealth.org

Kaiser Permanente Dublin
Dublin, California 94568
Contact:
Site Public Contact
877-642-4691

Mercy Cancer Center - Elk Grove
Elk Grove, California 95758
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Kaiser Permanente-Fremont
Fremont, California 94538
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Fresno Cancer Center
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Fresno
Fresno, California 93720
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
Contact:
Site Public Contact
877-827-8839
ucstudy@uci.edu

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

Kaiser Permanente-Modesto
Modesto, California 95356
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Oakland-Broadway
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Oakland
Oakland, California 94611
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Ontario
Ontario, California 91761
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

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

Kaiser Permanente-Rancho Cordova Cancer Center
Rancho Cordova, California 95670
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente- Marshall Medical Offices
Redwood City, California 94063
Contact:
Site Public Contact
877-642-4691

Kaiser Permanente-Richmond
Richmond, California 94801
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Mercy Cancer Center - Rocklin
Rocklin, California 95765
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Rohnert Park Cancer Center
Rohnert Park, California 94928
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Roseville
Roseville, California 95661
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California 95661
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Sutter Roseville Medical Center
Roseville, California 95661
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

The Permanente Medical Group-Roseville Radiation Oncology
Roseville, California 95678
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Downtown Commons
Sacramento, California 95814
Contact:
Site Public Contact
877-642-4691
kpoct@kp.org

Mercy Cancer Center - Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Kaiser Permanente-South Sacramento
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

South Sacramento Cancer Center
Sacramento, California 95823
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-San Diego Zion
San Diego, California 92120
Contact:
Site Public Contact
800-398-3996
clinical.trials@kp.org

California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Kaiser Permanente-San Francisco
San Francisco, California 94115
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente San Leandro
San Leandro, California 94577
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser San Rafael-Gallinas
San Rafael, California 94903
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Sutter Pacific Medical Foundation
Santa Rosa, California 95403
Contact:
Site Public Contact
415-209-2683
clinicalresearch@sutterhealth.org

Kaiser Permanente Cancer Treatment Center
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-South San Francisco
South San Francisco, California 94080
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Stockton
Stockton, California 95210
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Palo Alto Medical Foundation-Sunnyvale
Sunnyvale, California 94086
Contact:
Site Public Contact
clinicalresearch@sutterhealth.org

Kaiser Permanente Medical Center-Vacaville
Vacaville, California 95688
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Vallejo
Vallejo, California 94589
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
Contact:
Site Public Contact
877-642-4691
Kpoct@kp.org

John Muir Medical Center-Walnut Creek
Walnut Creek, California 94598
Contact:
Site Public Contact
925-941-4246
clinicalresearch@johnmuirhealth.com

Woodland Memorial Hospital
Woodland, California 95695
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907
Contact:
Site Public Contact
720-874-1881
ResearchInstituteInquiries@CommonSpirit.org

UCHealth Memorial Hospital Central
Colorado Springs, Colorado 80909
Contact:
Site Public Contact
719-365-2406

Memorial Hospital North
Colorado Springs, Colorado 80920
Contact:
Site Public Contact
719-364-6700

Poudre Valley Hospital
Fort Collins, Colorado 80524
Contact:
Site Public Contact
970-297-6150

Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado 80528
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado 80401
Contact:
Site Public Contact
peaksresearch@imail.org

UCHealth Greeley Hospital
Greeley, Colorado 80631
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Medical Center of the Rockies
Loveland, Colorado 80538
Contact:
Site Public Contact
970-203-7083

Baptist MD Anderson Cancer Center
Jacksonville, Florida 32207
Contact:
Site Public Contact
904-202-7468

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

Emory University Hospital Midtown
Atlanta, Georgia 30308
Contact:
Site Public Contact
888-946-7447

Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
Contact:
Site Public Contact
404-778-1868

Augusta University Medical Center
Augusta, Georgia 30912
Contact:
Site Public Contact
706-721-2388
ga_cares@augusta.edu

Memorial Health University Medical Center
Savannah, Georgia 31404
Contact:
Site Public Contact
912-350-7887
Lorraine.OHara@hcahealthcare.com

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

Advocate Good Shepherd Hospital
Barrington, Illinois 60010
Contact:
Site Public Contact
847-842-4847

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

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

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

Advocate Illinois Masonic Medical Center
Chicago, Illinois 60657
Contact:
Site Public Contact
773-296-5360

AMG Crystal Lake - Oncology
Crystal Lake, Illinois 60014
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocate.com

Carle at The Riverfront
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

Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Contact:
Site Public Contact
630-275-1270
Barbara.barhamand@advocatehealth.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

Advocate Sherman Hospital
Elgin, Illinois 60123
Contact:
Site Public Contact
847-429-2907

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

Advocate South Suburban Hospital
Hazel Crest, Illinois 60429
Contact:
Site Public Contact
708-799-9995

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

AMG Libertyville - Oncology
Libertyville, Illinois 60048
Contact:
Site Public Contact
630-929-6129
advocateresearch@advocatehealth.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

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

HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Advocate Christ Medical Center
Oak Lawn, Illinois 60453-2699
Contact:
Site Public Contact
800-323-8622

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

Advocate Lutheran General Hospital
Park Ridge, Illinois 60068
Contact:
Site Public Contact
847-384-3621

Illinois CancerCare-Pekin
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 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

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

Memorial Hospital East
Shiloh, Illinois 62269
Contact:
Site Public Contact
314-747-9912
dschwab@wustl.edu

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

Springfield Memorial Hospital
Springfield, Illinois 62781
Contact:
Site Public Contact
217-528-7541
pallante.beth@mhsil.com

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

Community Cancer Center East
Indianapolis, Indiana 46219
Contact:
Site Public Contact
317-497-2823
lcheri@ecommunity.com

Community Cancer Center South
Indianapolis, Indiana 46227
Contact:
Site Public Contact
317-497-2823
lcheri@ecommunity.com

Community Cancer Center North
Indianapolis, Indiana 46256
Contact:
Site Public Contact
317-497-2823
lcheri@ecommunity.com

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

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

Mission Cancer and Blood - Ankeny
Ankeny, Iowa 50023
Contact:
Site Public Contact
515-282-2921

Mercy Hospital
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-365-4673

Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
Contact:
Site Public Contact
319-363-2690

Mercy Cancer Center-West Lakes
Clive, Iowa 50325
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Mission Cancer and Blood - West Des Moines
Clive, Iowa 50325
Contact:
Site Public Contact
515-241-3305

Greater Regional Medical Center
Creston, Iowa 50801
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-241-3305

Siouxland Regional Cancer Center
Sioux City, Iowa 51101
Contact:
Site Public Contact
712-252-9326
HoopingarnerT@jencc.com

Mercy Medical Center-West Lakes
West Des Moines, Iowa 50266
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

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

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

University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
Contact:
Site Public Contact
913-588-3671
KUCC_Navigation@kumc.edu

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

Ascension Via Christi Hospitals Wichita
Wichita, Kansas 67214
Contact:
Site Public Contact
316-291-4774
research@viachristi.org

University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
Contact:
Site Public Contact
859-257-3379

The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
Contact:
Site Public Contact
502-562-3429

Norton Brownsboro Hospital and Medical Campus
Louisville, Kentucky 40241
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UofL Health Medical Center Northeast
Louisville, Kentucky 40245
Contact:
Site Public Contact
502-852-2755
ctoinfo@louisville.edu

Lafayette Family Cancer Center-EMMC
Brewer, Maine 04412
Contact:
Site Public Contact
800-987-3005

University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
Contact:
Site Public Contact
800-888-8823

Central Maryland Radiation Oncology in Howard County
Columbia, Maryland 21044
Contact:
Site Public Contact
443-546-1300

UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan 48106
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Brighton
Brighton, Michigan 48114
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health Medical Center - Canton
Canton, Michigan 48188
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Caro Cancer Center
Caro, Michigan 48723
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Health Saint John Hospital
Detroit, Michigan 48236
Contact:
Site Public Contact
313-343-3166
Kkeenan1@hfhs.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-267-1925
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, Michigan 48236
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.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

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

University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
Contact:
Site Public Contact
517-364-3712
harsha.trivedi@umhsparrow.org

Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Saint John Hospital - Macomb Medical
Macomb, Michigan 48044
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Saint Mary's Oncology/Hematology Associates of Marlette
Marlette, Michigan 48453
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

Michigan Healthcare Professionals Pontiac
Pontiac, Michigan 48341
Contact:
Site Public Contact
248-858-6215
Emily.Crofts@trinity-health.org

Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

MyMichigan Medical Center Saginaw
Saginaw, Michigan 48601
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Oncology Hematology Associates of Saginaw Valley PC
Saginaw, Michigan 48604
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

MyMichigan Medical Center Tawas
Tawas City, Michigan 48764
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.org

Henry Ford Health Warren Hospital
Warren, Michigan 48093
Contact:
Site Public Contact
313-343-3166
kforman1@hfhs.org

Saint Mary's Oncology/Hematology Associates of West Branch
West Branch, Michigan 48661
Contact:
Site Public Contact
989-907-8411
lori.srebinski@ascension.org

University of Michigan Health - West
Wyoming, Michigan 49519
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
Contact:
Site Public Contact
734-712-7251
MCRCwebsitecontactform@stjoeshealth.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

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 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

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

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

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

Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
Contact:
Site Public Contact
877-229-4907
coborncancercenter@centracare.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

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

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

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

Research Medical Center
Kansas City, Missouri 64132
Contact:
Site Public Contact
913-948-5588
aroland@kccop.org

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

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

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

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

BJC Outpatient Center at 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 Health Deaconess Hospital
Bozeman, Montana 59715
Contact:
Site Public Contact
406-969-6060
mccinfo@mtcancer.org

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

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

Saint Barnabas Medical Center
Livingston, New Jersey 07039
Contact:
Site Public Contact
973-322-2934
joanne.loeb@rwjbh.org

Jersey Shore Medical Center
Neptune, New Jersey 07753
Contact:
Site Public Contact
732-776-4240

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

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

Noyes Memorial Hospital/Myers Cancer Center
Dansville, New York 14437
Contact:
Site Public Contact
WCICTOresearch@urmc.rochester.edu

Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
Contact:
Site Public Contact
516-734-8896

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York 10032
Contact:
Site Public Contact
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

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

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
Contact:
Site Public Contact
877-668-0683
cancerclinicaltrials@med.unc.edu

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

Cleveland Clinic Akron General
Akron, Ohio 44307
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
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

Adena Regional Medical Center
Chillicothe, Ohio 45601
Contact:
Site Public Contact
877-779-7585
Jeffh@columbusccop.org

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Site Public Contact
216-778-7559
ababal@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

Riverside Methodist Hospital
Columbus, Ohio 43214
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

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

Premier Blood and Cancer Center
Dayton, Ohio 45409
Contact:
Site Public Contact
937-276-8320

Dayton Physician LLC - Englewood
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Hospital North
Dayton, Ohio 45415
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dublin Methodist Hospital
Dublin, Ohio 43016
Contact:
Site Public Contact
614-788-3860
Jennifer.Sexton@ohiohealth.com

Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
Contact:
Site Public Contact
937-569-7515

Wayne Hospital
Greenville, Ohio 45331
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Kettering Medical Center
Kettering, Ohio 45429
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

ProMedica Flower Hospital
Sylvania, Ohio 43560
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo, Ohio 43606
Contact:
Site Public Contact
419-824-1842
PCIOncResearch@promedica.org

Dayton Physicians LLC - Troy
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

Upper Valley Medical Center
Troy, Ohio 45373
Contact:
Site Public Contact
937-528-2900
clinical.trials@daytonncorp.org

University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Contact:
Site Public Contact
405-271-8777
ou-clinical-trials@ouhsc.edu

Legacy Mount Hood Medical Center
Gresham, Oregon 97030
Contact:
Site Public Contact
503-413-2150

Providence Newberg Medical Center
Newberg, Oregon 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Legacy Good Samaritan Hospital and Medical Center
Portland, Oregon 97210
Contact:
Site Public Contact
800-220-4937
cancer@lhs.org

Providence Saint Vincent Medical Center
Portland, Oregon 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Kaiser Permanente Northwest
Portland, Oregon 97227
Contact:
Site Public Contact
503-335-2400
information@kpchr.org

Legacy Meridian Park Hospital
Tualatin, Oregon 97062
Contact:
Site Public Contact
503-413-1742

Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
Contact:
Site Public Contact
610-402-9543
Morgan_M.Horton@lvhn.org

UPMC Altoona
Altoona, Pennsylvania 16601
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
Contact:
Site Public Contact
412-389-5208
haneydl@upmc.edu

UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Contact:
Site Public Contact
412-359-3043
ddefazio@wpahs.org

Forbes Hospital
Monroeville, Pennsylvania 15146
Contact:
Site Public Contact
412-858-7746

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Site Public Contact
877-284-2000

University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073

UPMC-Shadyside Hospital
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-621-2334

UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
Contact:
Site Public Contact
412-367-6454

Reading Hospital
West Reading, Pennsylvania 19611
Contact:
Site Public Contact
610-988-9323

Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Contact:
Site Public Contact
Dawnmarie.DeFazio@ahn.org

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
Contact:
Site Public Contact
605-312-3320
OncologyClinicTrialsSF@sanfordhealth.org

Avera Cancer Institute
Sioux Falls, South Dakota 57105
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
Contact:
Site Public Contact
605-312-3320
OncologyClinicalTrialsSF@SanfordHealth.org

Avera Cancer Institute at Yankton
Yankton, South Dakota 57078
Contact:
Site Public Contact
605-322-3095
OncRegulatory@avera.org

Parkland Memorial Hospital
Dallas, Texas 75235
Contact:
Site Public Contact
214-590-5582
canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
Contact:
Site Public Contact
214-648-7097
canceranswerline@UTSouthwestern.edu

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
713-798-1354
burton@bcm.edu

Ben Taub General Hospital
Houston, Texas 77030
Contact:
Site Public Contact
713-873-2000

American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah 84003
Contact:
Site Public Contact
801-855-4100
officeofresearch@imail.org

Sandra L Maxwell Cancer Center
Cedar City, Utah 84720
Contact:
Site Public Contact
435-868-5680
officeofresearch@imail.org

Logan Regional Hospital
Logan, Utah 84321
Contact:
Site Public Contact
435-716-6400
officeofresearch@imail.org

Intermountain Medical Center
Murray, Utah 84107
Contact:
Site Public Contact
801-507-3950
officeofresearch@imail.org

McKay-Dee Hospital Center
Ogden, Utah 84403
Contact:
Site Public Contact
801-387-7426
officeofresearch@imail.org

Utah Valley Regional Medical Center
Provo, Utah 84604
Contact:
Site Public Contact
801-357-7965
officeofresearch@imail.org

Riverton Hospital
Riverton, Utah 84065
Contact:
Site Public Contact
801-507-3950
officeofresearch@imail.org

Saint George Regional Medical Center
Saint George, Utah 84770
Contact:
Site Public Contact
833-321-3332
officeofresearch@imail.org

LDS Hospital
Salt Lake City, Utah 84143
Contact:
Site Public Contact
801-408-1347
officeofresearch@imail.org

Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont 05602
Contact:
Site Public Contact
802-225-5400

University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Site Public Contact
802-656-4101
rpo@uvm.edu

University of Vermont and State Agricultural College
Burlington, Vermont 05405
Contact:
Site Public Contact
802-656-8990
rpo@uvm.edu

Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
Contact:
Site Public Contact
800-639-6918
cancer.research.nurse@hitchcock.org

Inova Alexandria Hospital
Alexandria, Virginia 22304
Contact:
Site Public Contact
703-776-2580
Stephanie.VanBebber@inova.org

Inova Schar Cancer Institute
Fairfax, Virginia 22031
Contact:
Site Public Contact
703-720-5210
Stephanie.VanBebber@inova.org

Inova Fair Oaks Hospital
Fairfax, Virginia 22033
Contact:
Site Public Contact
703-720-5210
Stephanie.VanBebber@inova.org

Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
Contact:
Site Public Contact
804-893-8978
anne_carmellat@bshsi.org

Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia 23230
Contact:
Site Public Contact
804-893-8978
Anne_caramella@bshsi.org

VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Contact:
Site Public Contact
CTOclinops@vcu.edu

Virginia Mason Medical Center
Seattle, Washington 98101
Contact:
Site Public Contact
206-287-6275
cancerresearch@virginiamason.org

Legacy Cancer Institute Medical Oncology and Day Treatment
Vancouver, Washington 98684
Contact:
Site Public Contact
oncologyresearch@lhs.org

Legacy Salmon Creek Hospital
Vancouver, Washington 98686
Contact:
Site Public Contact
503-413-2150

Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Contact:
Site Public Contact
715-623-9869
Juli.Alford@aspirus.org

Duluth Clinic Ashland
Ashland, Wisconsin 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin 53105
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Health Care Germantown Health Center
Germantown, Wisconsin 53022
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Grafton
Grafton, Wisconsin 53024
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Aurora BayCare Medical Center
Green Bay, Wisconsin 54311
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

University of Wisconsin Carbone Cancer Center - Johnson Creek
Johnson Creek, Wisconsin 53038
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin 53142
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
Contact:
Site Public Contact
608-775-2385
cancerctr@gundersenhealth.org

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
clinicaltrials@cancer.wisc.edu

Aurora Bay Area Medical Group-Marinette
Marinette, Wisconsin 54143
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin 53209
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Sinai Medical Center
Milwaukee, Wisconsin 53233
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
Contact:
Site Public Contact
research.institute@phci.org

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

ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
Contact:
Site Public Contact
262-928-7878

Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin 54904
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aurora Cancer Care-Racine
Racine, Wisconsin 53406
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Aspirus Cancer Care - James Beck Cancer Center
Rhinelander, Wisconsin 54501
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin 53081
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
Contact:
Site Public Contact
218-786-3308
CancerTrials@EssentiaHealth.org

Aspirus Cancer Care - Stevens Point
Stevens Point, Wisconsin 54481
Contact:
Site Public Contact
715-847-2353
Beth.Knetter@aspirus.org

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
Contact:
Site Public Contact
920-433-8889
ewd_research_admin@hshs.org

Aurora Medical Center in Summit
Summit, Wisconsin 53066
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin 54880
Contact:
Site Public Contact
701-364-6272

Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin 54241
Contact:
Site Public Contact
414-302-2304
ncorp@aurora.org

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

Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866

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

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

Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718

More Details

NCT ID
NCT05095376
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

PRIMARY OBJECTIVE: I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs overall survival (OS) versus (vs.) standard chemoradiotherapy with temozolomide in patients with newly diagnosed glioblastoma (GBM) with MGMT promoter methylation. SECONDARY OBJECTIVES: I. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) significantly prolongs progression-free survival (PFS) vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation. II. To compare the two different chemotherapy regimens on patient-reported outcomes (PROs), as measured by the MD Anderson Symptom Inventory - Brain Tumor (MDASI-BT) in patients with newly diagnosed GBM with MGMT promoter methylation. III. To determine if the regimen with the two alkylating agents temozolomide and lomustine with radiotherapy (RT) is associated with inferior short-term change in patient reported outcomes (PROs) as measured by MDASI-BT vs. standard chemoradiotherapy with temozolomide in patients with newly diagnosed GBM with MGMT promoter methylation. IV. To assess toxicity in the two different chemotherapy regimens. EXPLORATORY OBJECTIVES: I. To assess the association between absolute lymphocyte counts and outcomes. II. To assess the association between CD4+ lymphocyte counts and outcomes. III. To compare the two different chemotherapy regimens in terms of long-term PROs as measured by MDASI-BT at years 1 and 2. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo radiation therapy 5 days per week and receive temozolomide orally (PO) once daily (QD) for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. ARM II: Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive lomustine PO on day 1 and temozolomide PO QD on days 2-6. Treatment repeats every 42 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for year 1, every 4 months for year 2, and then every 6 months thereafter.