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Purpose

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without stereotactic body radiation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, and gemcitabine 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. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Giving maintenance chemotherapy and stereotactic body radiation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Conditions

Eligibility

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

Inclusion Criteria

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
  • Women of childbearing potential and men who are sexually active should be willing and able to use medically acceptable forms of contraception during the trial
  • Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration; this includes patients newly diagnosed with metastatic disease or those initially diagnosed and treated for stage I-III NSCLC who ultimately develop metastases
  • Appropriate stage for study entry based on the following diagnostic workup:
  • History/physical examination within 30 days prior to registration
  • Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least CT chest through the adrenals or PET/CT within 30 days prior to registration
  • Zubrod performance status 0, 1, or 2 within 30 days prior to registration
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 × upper limit of normal (ULN) or ≤ 5 × ULN with metastatic liver disease
  • Total bilirubin ≤ 1.5 × ULN
  • Absolute neutrophil count (ANC) ≥ 500 cells/mm^3
  • Creatinine clearance ≥ 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
  • Platelets ≥ 50,000 cells/mm^3
  • Negative serum pregnancy test within one week prior to registration for females of childbearing potential
  • Patients must have received first-line/induction chemotherapy (4 cycles) and achieved stable disease or a partial response
  • Prior systemic chemotherapy as part of concurrent treatment approach for previously diagnosed stage III NSCLC, as adjuvant therapy for previously resected NSCLC, or for other previous cancers is permitted
  • Prior radiotherapy for patients with brain metastases prior to enrollment is acceptable
  • Patients must have measurable disease at baseline and 3 or fewer discrete, extracranial metastatic disease sites that are technically amenable to SBRT
  • For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation; if the primary disease is found in the peripheral or central lung parenchyma without nodal disease for instance, SBRT may be employed; if primary disease is more advanced with involvement of the mediastinum (T4 tumor, N1-N3 disease, etc.), these volumes should be technically treatable with hypofractionated radiation
  • If primary disease in the thoracic cavity was previously treated with local therapy in the form of surgery, any local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation after induction systemic therapy
  • Patients must be registered within 35 days of administration of the last dose of first-line/induction systemic therapy
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Patients with brain metastases are eligible if these lesions have been previously treated and the patients have no clinical or radiographic evidence of progression prior to enrollment

Exclusion Criteria

  • Clinical or radiologic evidence of untreated and/or progressive brain metastases
  • Cutaneous metastasis of NSCLC
  • Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes
  • Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
  • Metastases located within 3 cm of previously irradiated (< 3Gy per fraction) structures if:
  • Spinal cord previously irradiated to > 40 Gy
  • Brachial plexus previously irradiated to > 50 Gy
  • Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
  • Brainstem previously irradiated to > 50 Gy
  • Lung previously irradiated with prior V20 Gy > 35%
  • Patients receiving targeted therapy (non-cytotoxic systemic therapy) for NSCLC in the first-line setting
  • If a patient has progressed in previous areas of primary disease that received definitive doses of radiation, these patients would require re-irradiation in previous high dose anatomic areas and are not eligible for this study
  • Patients with malignant pleural effusions that do not resolve after first-line systemic therapy; patients with pleural effusions that have become too small for thoracentesis at the time of registration would be permitted on study, indicating a significant response to first-line chemotherapy
  • Patients with more than 3 discrete locations of extra-cranial metastatic disease after first-line systemic therapy requiring more than 3 SBRT plans to cover these distinct metastatic disease entities
  • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  • Patients who are pregnant or nursing
  • Participation in any investigational drug study (excluding non-oncology and/or symptom management studies) within 4 weeks prior to registration
  • Known human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol

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 1 (maintenance chemotherapy) 		Patients may receive docetaxel IV over 60 minutes on Day 1, or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Drug: Docetaxel
    Given IV
    Other names:
    • Docecad
    • RP56976
    • Taxotere
    • Taxotere Injection Concentrate
  • Drug: Gemcitabine
    Given IV
    Other names:
    • dFdC
    • dFdCyd
    • Difluorodeoxycytidine
  • Drug: Pemetrexed Disodium
    Given IV
    Other names:
    • Alimta
    • LY231514
    • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
Experimental
Arm 2 (SBRT + maintenance chemotherapy) 		Patients undergo SBRT over 2-4 weeks. If SBRT cannot be used to treat primary disease sites, patients also undergo IMRT or 3D-CRT over 3-5 weeks. Within 2 weeks after completion of radiation therapy, patients receive chemotherapy as in Arm 1 (docetaxel IV over 60 minutes on Day 1, or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1).
  • Radiation: 3-Dimensional Conformal Radiation Therapy (3D-CRT)
    Undergo 3DCRT
    Other names:
    • 3-dimensional conformal radiation therapy
    • 3-dimensional radiation therapy
    • 3D CONFORMAL RADIATION THERAPY
    • 3D CRT
    • 3D-CRT
    • Conformal Therapy
    • Radiation Conformal Therapy
  • Drug: Docetaxel
    Given IV
    Other names:
    • Docecad
    • RP56976
    • Taxotere
    • Taxotere Injection Concentrate
  • Drug: Gemcitabine
    Given IV
    Other names:
    • dFdC
    • dFdCyd
    • Difluorodeoxycytidine
  • Radiation: Intensity-Modulated Radiation Therapy (IMRT)
    Undergo IMRT
    Other names:
    • IMRT
    • Intensity Modulated RT
    • INTENSITY-MODULATED RADIATION THERAPY
    • Intensity-Modulated Radiotherapy
  • Drug: Pemetrexed Disodium
    Given IV
    Other names:
    • Alimta
    • LY231514
    • N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
  • Radiation: Stereotactic Body Radiation Therapy (SBRT)
    Undergo SBRT
    Other names:
    • SBRT
    • stereotactic body radiation therapy

Recruiting Locations

Arizona Breast Cancer Specialists-Gilbert
Gilbert, Arizona 85297
Contact:
Site Public Contact
480-922-4600

Arizona Center for Cancer Care-Peoria
Peoria, Arizona 85381
Contact:
Site Public Contact
623-773-2873

Mayo Clinic Hospital
Phoenix, Arizona 85054
Contact:
Site Public Contact
855-776-0015

Arizona Breast Cancer Specialists-Scottsdale
Scottsdale, Arizona 85258
Contact:
Site Public Contact
480-922-4600

Mayo Clinic in Arizona
Scottsdale, Arizona 85259
Contact:
Site Public Contact
855-776-0015

University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona 85704
Contact:
Site Public Contact
520-694-8900

The University of Arizona Medical Center-University Campus
Tucson, Arizona 85724
Contact:
Site Public Contact
520-626-9008

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

Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

City of Hope Comprehensive Cancer Center
Duarte, California 91010
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

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

Los Angeles County-USC Medical Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Site Public Contact
323-865-0451

Saint Joseph Hospital - Orange
Orange, California 92868
Contact:
Site Public Contact
714-734-6220

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

Sutter Medical Center Sacramento
Sacramento, California 95816
Contact:
Site Public Contact
415-209-2686
bernicl@sutterhealth.org

University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
Contact:
Site Public Contact
916-734-3089

Saint Helena Hospital
Saint Helena, California 94574
Contact:
Site Public Contact
707-967-3698

City of Hope South Pasadena
South Pasadena, California 91030
Contact:
Site Public Contact
800-826-4673
becomingapatient@coh.org

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

Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California 96161
Contact:
Site Public Contact
530-582-6450

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

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

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

Yale University
New Haven, Connecticut 06520
Contact:
Site Public Contact
203-785-5702
canceranswers@yale.edu

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

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

University of Florida Health Science Center - Gainesville
Gainesville, Florida 32610
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
Site Public Contact
855-776-0015

Tallahassee Memorial HealthCare
Tallahassee, Florida 32308
Contact:
Site Public Contact
850-431-5566
Theresa.Shannon@tmh.org

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

Grady Health System
Atlanta, Georgia 30303
Contact:
Site Public Contact
404-489-9164

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

Emory Saint Joseph's Hospital
Atlanta, Georgia 30342
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405
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412-339-5294
Roster@nrgoncology.org

Queen's Medical Center
Honolulu, Hawaii 96813
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412-339-5294
Roster@nrgoncology.org

The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817
Contact:
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808-547-6881

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

Decatur Memorial Hospital
Decatur, Illinois 62526
Contact:
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217-876-4740
rhamrick@dmhhs.org

Crossroads Cancer Center
Effingham, Illinois 62401
Contact:
Site Public Contact
217-876-4740
rhamrick@dmhhs.org

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

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

Southwest Illinois Health Services LLP
Swansea, Illinois 62226
Contact:
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618-236-1000
lynns@thecancercenter.com

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

Parkview Hospital Randallia
Fort Wayne, Indiana 46805
Contact:
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260-373-8888
parkviewresearch@parkview.com

Goshen Center for Cancer Care
Goshen, Indiana 46526
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574-364-2973
cccois@goshenhealth.com

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

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

Franciscan Health Indianapolis
Indianapolis, Indiana 46237
Contact:
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317-528-7060

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

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

University of Kansas Cancer Center
Kansas City, Kansas 66160
Contact:
Site Public Contact
913-945-7552
ctnursenav@kumc.edu

University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
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Site Public Contact
913-945-7552
ctnursenav@kumc.edu

Via Christi Regional Medical Center
Wichita, Kansas 67214
Contact:
Site Public Contact
800-362-0070
Keisha.humphries@ascension.org

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

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

Tate Cancer Center
Glen Burnie, Maryland 21061
Contact:
Site Public Contact
410-553-8100

Peninsula Regional Medical Center
Salisbury, Maryland 21801
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Site Public Contact
866-922-6237

Boston Medical Center
Boston, Massachusetts 02118
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617-638-8265

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
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781-744-8027

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
Contact:
Site Public Contact
313-916-1784

Henry Ford Hospital
Detroit, Michigan 48202
Contact:
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313-916-1784

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

Sanford Clinic North-Bemidgi
Bemidji, Minnesota 56601
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Site Public Contact
218-333-5000

Saint Luke's Hospital of Duluth
Duluth, Minnesota 55805
Contact:
Site Public Contact
412-339-5294
Roster@nrgoncology.org

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

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

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

Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Contact:
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314-251-6770

Benefis Healthcare- Sletten Cancer Institute
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

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

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

Wentworth-Douglass Hospital
Dover, New Hampshire 03820
Contact:
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603-740-2150

Community Medical Center
Toms River, New Jersey 08755
Contact:
Site Public Contact
732-818-3882

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

Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico 87505
Contact:
Site Public Contact
505-913-8933
Olivia.Sloan@nmcancercare.com

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

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

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

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

Stony Brook University Medical Center
Stony Brook, New York 11794
Contact:
Site Public Contact
800-862-2215

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Site Public Contact
888-275-3853

NHRMC Radiation Oncology - Supply
Supply, North Carolina 28462
Contact:
Site Public Contact
910-754-4716

New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-342-3000

NHRMC Radiation Oncology - 16th Street
Wilmington, North Carolina 28401
Contact:
Site Public Contact
910-251-1839

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

Roger Maris Cancer Center
Fargo, North Dakota 58122
Contact:
Site Public Contact
701-234-6161

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

University of Cincinnati/Barrett Cancer Center
Cincinnati, Ohio 45219
Contact:
Site Public Contact
513-558-4553
uchealthnews@uc.edu

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

Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio 44111
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

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

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

The Mark H Zangmeister Center
Columbus, Ohio 43219
Contact:
Site Public Contact
614-488-2118
sheree@columbusccop.org

Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio 44906
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio 44124
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

North Coast Cancer Care
Sandusky, Ohio 44870
Contact:
Site Public Contact
866-223-8100
CancerAnswer@ccf.org

University Pointe
West Chester, Ohio 45069
Contact:
Site Public Contact
clinicaltrials@ucphysicians.com

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

Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402

Good Samaritan Hospital
Corvallis, Oregon 97330
Contact:
Site Public Contact
541-768-4352
stmock@samhealth.org

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

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

Providence Portland Medical Center
Portland, Oregon 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

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

Bryn Mawr Hospital
Bryn Mawr, Pennsylvania 19010
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Geisinger Medical Center
Danville, Pennsylvania 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Delaware County Memorial Hospital
Drexel Hill, Pennsylvania 19026
Contact:
Site Public Contact
610-284-8237
jolene.garney@crozer.org

UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
Contact:
Site Public Contact
717-724-6765
klitchfield@PINNACLEHEALTH.org

Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Contact:
Site Public Contact
215-955-6084

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

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

Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Contact:
Site Public Contact
484-476-2649
turzoe@mlhs.org

Greenville Health System Cancer Institute-Faris
Greenville, South Carolina 29605
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina 29615
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Self Regional Healthcare
Greenwood, South Carolina 29646
Contact:
Site Public Contact
864-725-4771
nmcgaha@selfregional.org

Gibbs Cancer Center-Pelham
Greer, South Carolina 29651
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina 29926
Contact:
Site Public Contact
912-819-5704
underberga@sjchs.org

Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina 29672
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

Spartanburg Medical Center
Spartanburg, South Carolina 29303
Contact:
Site Public Contact
864-560-6104
kmertz-rivera@gibbscc.org

Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina 29307
Contact:
Site Public Contact
864-241-6251
kwilliams8@ghs.org

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

Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
Contact:
Site Public Contact
901-226-1366
BCCclintrials@bmhcc.org

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

M D Anderson Cancer Center
Houston, Texas 77030
Contact:
Site Public Contact
877-312-3961

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Site Public Contact
210-450-3800
phoresearchoffice@uthscsa.edu

West Virginia University Healthcare
Morgantown, West Virginia 26506
Contact:
Site Public Contact
304-293-7374
cancertrialsinfo@hsc.wvu.edu

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

Aurora Health Center-Fond du Lac
Fond Du Lac, Wisconsin 54937
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

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

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

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
412-339-5294
Roster@nrgoncology.org

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

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

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

Marshfield Clinic Stevens Point Center
Stevens Point, Wisconsin 54482
Contact:
Site Public Contact
800-782-8581
oncology.clinical.trials@marshfieldresearch.org

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

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

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

More Details

NCT ID
NCT03137771
Status
Recruiting
Sponsor
NRG Oncology

Detailed Description

PRIMARY OBJECTIVES:

Phase II

To evaluate the impact of adding stereotactic body radiation therapy (SBRT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy.

Phase III

To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy.

SECONDARY OBJECTIVES:

I. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure.

II. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on primary failure.

III. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on out-of-field disease progression.

IV. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity.

V. To evaluate the impact of adding SBRT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic chemotherapy usage.

VI. To evaluate the effect of adding SBRT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL)

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM 1 (CHEMOTHERAPY ALONE): Patients may receive docetaxel intravenously (IV) over 60 minutes on Day 1, or gemcitabine IV over 30 minutes on Days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on Day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM 2 (SBRT AND CHEMOTHERAPY): Patients undergo SBRT to all sites of metastases (≤3 discrete sites) plus irradiation of the primary site (SBRT or hypofractionated RT) followed by chemotherapy as in Arm 1.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.