High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444) in Patients With Stage IIIA/IIIB Non-Small Cell Lung Cancer
5 other identifiers
interventional
544
2 countries
213
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel, carboplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy with or without cetuximab in treating patients with non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying high-dose or standard-dose radiation therapy given together with chemotherapy with or without cetuximab to see how well they work in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 lung-cancer
Started Nov 2007
Longer than P75 for phase_3 lung-cancer
213 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedResults Posted
Study results publicly available
May 5, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedJune 21, 2022
May 1, 2022
5.6 years
September 20, 2007
January 17, 2017
May 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.
Secondary Outcomes (12)
Progression-free Survival
From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.
Local-regional Failure (Reported as Two-year Estimates)
From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.
Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0
From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.
Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.
Death During or Within 30 Days of Discontinuation of Protocol Treatment
From start of protocol treatment to 24 months.
- +7 more secondary outcomes
Study Arms (4)
60 Gy RT
ACTIVE COMPARATOR60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
74 Gy RT
EXPERIMENTAL74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin
60 Gy RT + Cetuximab
EXPERIMENTAL60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
74 Gy RT + Cetuximab
EXPERIMENTAL74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Interventions
Loading dose: 400 mg/m2, IV, one week prior to start of radiation therapy (RT). Then, beginning day 1 of RT, 250 mg/m2, IV, weekly; for 60 Gy arm for 15 weeks, for 74 Gy arm for 16 weeks.
Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy; for 74 Gy arms, on day 43 as well. Consolidation, 3 weeks after completion of RT, AUC=6, IV, days 1 and 22.
Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy (RT); for 74 Gy arms, on day 43 as well. Consolidation, 3 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22.
Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.
Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.
Eligibility Criteria
You may qualify if:
- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC); excluding patients with N3 disease based on supraclavicular or contralateral hilar adenopathy, \[according to American Joint Committee on Cancer (AJCC) Staging, 6th edition; see appendix III\] within 12 weeks of registration; patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor also are eligible.
- Patients must be considered unresectable or inoperable; Note: Patients who have had a nodal recurrence after surgery for an early-stage NSCLC are eligible if the following criteria are met:
- Nodal recurrence must be N1 or N2; N3 is not eligible.
- The initial primary must have been staged as T1-2, N0, M0.
- The node must be biopsied within 12 weeks of registration.
- The node must be measurable.
- The patient must not have received prior chemotherapy or radiation for this lung cancer.
- Prior curative surgery must have been at least 6 months prior to the nodal recurrence.
- The exception to a prior invasive malignancy does not apply to the initial lung primary.
- Stage III A or B disease, including no distant metastases, based upon the following minimum diagnostic workup are acceptable:
- History/physical examination, including documentation of height, weight, body surface area (BSA), and vital signs within 8 weeks prior to registration;
- Computed tomographic (CT)/Magnetic Resonance Imaging (MRI) imaging of the lung and upper abdomen through the adrenal glands within 6 weeks prior to registration;
- An MRI of the brain with contrast (or CT with contrast if MRI is medically contraindicated) within 6 weeks prior to registration; Note: The use of intravenous contrast is required for the MRI or CT. An MRI without contrast is only permitted if the patient has a contrast allergy.
- Whole-body fluorodeoxyglucose (FDG) - Positron Emission Tomography(PET) or PET/CT or if no PET is available, a bone scan is required within 6 weeks prior to registration; Note: If a PET is done that shows clear adrenals and lungs, then a CT scan of chest only is permitted.
- If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable T4 disease):
- +17 more criteria
You may not qualify if:
- N3 supraclavicular disease;
- Greater than minimal, exudative, or cytologically positive pleural effusions;
- Involved contralateral hilar nodes (i.e. greater than 1.5 cm on short axis or positive on PET scan);
- ≥ 10% weight loss within the past month;
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
- Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway;
- Prior severe infusion reaction to a monoclonal antibody;
- Severe, active co-morbidity, defined as follows:
- Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, myocardial infarction within the last 6 months, uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radiation Therapy Oncology Grouplead
- National Cancer Institute (NCI)collaborator
- North Central Cancer Treatment Groupcollaborator
- Cancer and Leukemia Group Bcollaborator
- NRG Oncologycollaborator
Study Sites (213)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259-5499, United States
Arizona Oncology - Tucson
Tucson, Arizona, 85704, United States
Mercy Cancer Center at Mercy San Juan Medical Center
Carmichael, California, 95608, United States
Enloe Cancer Center at Enloe Medical Center
Chico, California, 95926, United States
Cancer Care Center at John Muir Health - Concord Campus
Concord, California, 94524-4110, United States
Saint Agnes Cancer Center at Saint Agnes Medical Center
Fresno, California, 93720, United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658, United States
Memorial Medical Center
Modesto, California, 95355, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868, United States
Feather River Hospital Cancer Center
Paradise, California, 95969, United States
Radiation Oncology Center - Roseville
Roseville, California, 95661, United States
Radiological Associates of Sacramento Medical Group, Incorporated
Sacramento, California, 95815, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115, United States
Saint Helena Hospital
St. Helena, California, 94574, United States
Stanford Cancer Center
Stanford, California, 94305-5824, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
Poudre Valley Radiation Oncology
Fort Collins, Colorado, 80528, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, 33316, United States
University of Florida Shands Cancer Center
Gainesville, Florida, 32610-0232, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, 32207, United States
Integrated Community Oncology Network at Southside Cancer Center
Jacksonville, Florida, 32207, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, 32224, United States
Baptist Medical Center South
Jacksonville, Florida, 32258, United States
Integrated Community Oncology Network
Jacksonville Beach, Florida, 32250, United States
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
Jupiter, Florida, 33458, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, 33176, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Integrated Community Oncology Network - Orange Park
Orange Park, Florida, 32073, United States
M.D. Anderson Cancer Center at Orlando
Orlando, Florida, 32806, United States
Florida Cancer Center - Palatka
Palatka, Florida, 32177, United States
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Flagler Cancer Center
Saint Augustine, Florida, 32086, United States
Georgia Cancer Center for Excellence at Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, 30033, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, 83712, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Chicago, Illinois, 60657, United States
Community Cancer Center
Normal, Illinois, 61761, United States
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637, United States
Radiation Oncology Associates Southwest
Fort Wayne, Indiana, 46804, United States
Parkview Regional Cancer Center at Parkview Health
Fort Wayne, Indiana, 46805, United States
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, 46526, United States
Central Indiana Cancer Centers - East
Indianapolis, Indiana, 46219, United States
Community Regional Cancer Care at Community Hospital East
Indianapolis, Indiana, 46219, United States
Community Regional Cancer Care at Community Hospital North
Indianapolis, Indiana, 46256, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Central Baptist Hospital
Lexington, Kentucky, 40503-9985, United States
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, 71315-3198, United States
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, 70809, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112, United States
CCOP - Ochsner
New Orleans, Louisiana, 70121, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
St. Agnes Hospital Cancer Center
Baltimore, Maryland, 21229, United States
Shore Regional Cancer Center at Memorial Hospital - Easton
Easton, Maryland, 21601, United States
Peninsula Regional Medical Center
Salisbury, Maryland, 21801, United States
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, 01107, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, 48106-0995, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, 49503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, 48236, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
St. Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, 48060, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, 56303, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, 63110, United States
Barnes-Jewish West County Hospital
St Louis, Missouri, 63141, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990, United States
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, 68114, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, 89502, United States
Saint Mary's Regional Medical Center
Reno, Nevada, 89503, United States
Payson Center for Cancer Care at Concord Hospital
Concord, New Hampshire, 03301, United States
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, 03833, United States
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, 03103, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
UMDNJ University Hospital
Newark, New Jersey, 07103, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
New York Oncology Hematology, PC at Albany Regional Cancer Care
Albany, New York, 12206, United States
Veterans Affairs Medical Center - Albany
Albany, New York, 12208, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, 10025, United States
Highland Hospital of Rochester
Rochester, New York, 14620, United States
University Radiation Oncology at Parkridge Hospital
Rochester, New York, 14626, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642, United States
SUNY Upstate Medical University Hospital
Syracuse, New York, 13210, United States
Alamance Cancer Center at Alamance Regional Medical Center
Burlington, North Carolina, 27216, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, 28233-3549, United States
Kinston Medical Specialists
Kinston, North Carolina, 28501, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, 28374, United States
Cancer Centers of North Carolina - Raleigh
Raleigh, North Carolina, 27607, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, 58201, United States
Trinity CancerCare Center
Minot, North Dakota, 58701, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090, United States
Barberton Citizens Hospital
Barberton, Ohio, 44203, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998, United States
Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Southwest General Health Center
Middleburg Heights, Ohio, 44130, United States
UHHS Chagrin Highlands Medical Center
Orange, Ohio, 44122, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
UHHS Westlake Medical Center
Westlake, Ohio, 44145, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136, United States
Willamette Valley Cancer Center - Eugene
Eugene, Oregon, 97401, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, 18105, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, 17822-0001, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, 18301, United States
Regional Cancer Center - Erie
Erie, Pennsylvania, 16505, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, 19111-2497, United States
Frankford Hospital Cancer Center - Torresdale Campus
Philadelphia, Pennsylvania, 19114, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, 29605, United States
CCOP - Greenville
Greenville, South Carolina, 29615, United States
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, 29672, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
Kingsport, Tennessee, 37662, United States
Harrington Cancer Center
Amarillo, Texas, 79106, United States
Texas Oncology, PA at Texas Cancer Center - Arlington South
Arlington, Texas, 76014, United States
Texas Oncology, PA at Harris Center HEB
Bedford, Texas, 76022, United States
Texas Oncology, PA at Texas Cancer Center - Denton South
Denton, Texas, 76210, United States
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009, United States
Longview Cancer Center
Longview, Texas, 75601, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Cancer Care Centers of South Texas - Northeast
San Antonio, Texas, 78217, United States
Texas Oncology, PA at Texas Cancer Center - Sherman
Sherman, Texas, 75090, United States
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Sugar Land, Texas, 77479, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106, United States
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, 98101, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Theda Care Cancer Institute
Appleton, Wisconsin, 54911, United States
Midelfort Clinic - Luther
Eau Claire, Wisconsin, 54703-1510, United States
Luther Midlelfort Hospital
Eau Claire, Wisconsin, 54703, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, 53295, United States
D.N. Greenwald Center
Mukwonago, Wisconsin, 53149, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, 53405, United States
Door County Cancer Center at Door County Memorial Hospital
Sturgeon Bay, Wisconsin, 54235-1495, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, 54494, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, T2N 4N2, Canada
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre at the University of Saskatchewan
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (7)
Bradley JD, Hu C, Komaki RR, Masters GA, Blumenschein GR, Schild SE, Bogart JA, Forster KM, Magliocco AM, Kavadi VS, Narayan S, Iyengar P, Robinson CG, Wynn RB, Koprowski CD, Olson MR, Meng J, Paulus R, Curran WJ Jr, Choy H. Long-Term Results of NRG Oncology RTOG 0617: Standard- Versus High-Dose Chemoradiotherapy With or Without Cetuximab for Unresectable Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2020 Mar 1;38(7):706-714. doi: 10.1200/JCO.19.01162. Epub 2019 Dec 16.
PMID: 31841363RESULTChun SG, Hu C, Komaki RU, Timmerman RD, Schild SE, Bogart JA, Dobelbower MC, Bosch W, Kavadi VS, Narayan S, Iyengar P, Robinson C, Rothman J, Raben A, Augspurger ME, MacRae RM, Paulus R, Bradley JD. Long-Term Prospective Outcomes of Intensity Modulated Radiotherapy for Locally Advanced Lung Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2024 Aug 1;10(8):1111-1115. doi: 10.1001/jamaoncol.2024.1841.
PMID: 38935373DERIVEDZhang Z, Wang Z, Luo T, Yan M, Dekker A, De Ruysscher D, Traverso A, Wee L, Zhao L. Computed tomography and radiation dose images-based deep-learning model for predicting radiation pneumonitis in lung cancer patients after radiation therapy. Radiother Oncol. 2023 May;182:109581. doi: 10.1016/j.radonc.2023.109581. Epub 2023 Feb 25.
PMID: 36842666DERIVEDMcWilliam A, Abravan A, Banfill K, Faivre-Finn C, van Herk M. Demystifying the Results of RTOG 0617: Identification of Dose Sensitive Cardiac Subregions Associated With Overall Survival. J Thorac Oncol. 2023 May;18(5):599-607. doi: 10.1016/j.jtho.2023.01.085. Epub 2023 Feb 3.
PMID: 36738929DERIVEDMcKenzie E, Zhang S, Zakariaee R, Guthier CV, Hakimian B, Mirhadi A, Kamrava M, Padda SK, Lewis JH, Nikolova A, Mak RH, Atkins KM. Left Anterior Descending Coronary Artery Radiation Dose Association With All-Cause Mortality in NRG Oncology Trial RTOG 0617. Int J Radiat Oncol Biol Phys. 2023 Apr 1;115(5):1138-1143. doi: 10.1016/j.ijrobp.2022.11.033. Epub 2022 Nov 24.
PMID: 36436615DERIVEDMovsas B, Hu C, Sloan J, Bradley J, Komaki R, Masters G, Kavadi V, Narayan S, Michalski J, Johnson DW, Koprowski C, Curran WJ Jr, Garces YI, Gaur R, Wynn RB, Schallenkamp J, Gelblum DY, MacRae RM, Paulus R, Choy H. Quality of Life Analysis of a Radiation Dose-Escalation Study of Patients With Non-Small-Cell Lung Cancer: A Secondary Analysis of the Radiation Therapy Oncology Group 0617 Randomized Clinical Trial. JAMA Oncol. 2016 Mar;2(3):359-67. doi: 10.1001/jamaoncol.2015.3969.
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PMID: 25601342DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Cetuximab arms were added after the study opened, therefore the first 34 patients were excluded from cetuximab analysis. High dose RT arms closed early (at n=474), therefore later patients enrolled to low dose RT arm were excluded from RT analysis.
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Bradley, MD
Mallinckrodt Institute of Radiology at Washington University Medical Center
- STUDY CHAIR
Hak Choy, MD
Simmons Cancer Center
- STUDY CHAIR
Gregory A. Masters, MD
CCOP - Christiana Care Health Services
- STUDY CHAIR
Steven E. Schild, MD
Mayo Clinic
- STUDY CHAIR
Alex A. Adjei, MD, PhD
Roswell Park Cancer Institute
- STUDY CHAIR
Jeffrey A. Bogart, MD
State University of New York - Upstate Medical University
- STUDY CHAIR
Arthur William Blackstock, MD
Wake Forest University Health Sciences
- STUDY CHAIR
Mark A. Socinski, MD
UNC Lineberger Comprehensive Cancer Center
- STUDY CHAIR
George Blumenschein, MD
M.D. Anderson Cancer Center
- STUDY CHAIR
Ritsuko Komaki, MD
M.D. Anderson Cancer Center
- STUDY CHAIR
Jeff Sloan, PhD, HSR
Mayo Clinic
- STUDY CHAIR
Mark Dobelbower, MD PhD
University of Alabama Medical Center
- STUDY CHAIR
Tien Hoang, MD
University of Wisconsin, Madison
- STUDY CHAIR
Ken Forster, PhD
H. Lee Moffitt Cancer Center
- STUDY CHAIR
Benjamin Movsas, MD
Henry Ford Hospital
- STUDY CHAIR
Joe Y. Chang, MD PhD
M.D. Anderson Cancer Center
- STUDY CHAIR
Joseph O. Deasy, PhD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
November 1, 2007
Primary Completion
June 1, 2013
Study Completion
May 20, 2022
Last Updated
June 21, 2022
Results First Posted
May 5, 2017
Record last verified: 2022-05