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

NCT ID: NCT00533949

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 544 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2022-05-20

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.

Detailed Description

OBJECTIVES:

Primary

• To compare the overall survival of patients with newly diagnosed, unresectable stage IIIA or IIIB non-small cell lung cancer treated with high- versus standard-dose conformal radiotherapy with concurrent and consolidation chemotherapy comprising carboplatin and paclitaxel.
• To compare the overall survival of patients treated with versus without cetuximab in the setting of concurrent chemotherapy

Secondary

• To compare progression-free survival and local-regional tumor control in patients treated with these regimens.
• To compare the toxicity of high- versus standard-dose conformal radiotherapy and concurrent chemotherapy with versus without cetuximab in these patients.
• To investigate the prognostic and predictive effects of gross tumor volume on overall survival of patients treated with these regimens.
• To compare the quality of life of patients treated with these regimens.
• To correlate outcomes (i.e., survival, toxicity, or QOL) in these patients with biological parameters.
• To analyze the predictive value of pre-treatment standardized uptake value (SUV) of positron emission tomography (PET) scan in predicting survival, distant metastasis, and local-regional control in patients treated with these regimens.
• To explore biological markers to predict clinical outcome including survival, distant metastasis, local-regional control, and QOL (including toxicity) in patients treated with these regimens.
• To prospectively collect and bank tissue, blood, and urine specimens for future biomarker analyses in predicting clinical outcome in patients treated with these regimens.
• To investigate associations between epidermal growth factor receptor (EGFR) expression and toxicity, response, overall survival, and progression-free survival.

OUTLINE: This is a multicenter study. Patients are stratified according to PET staging (yes vs no), radiotherapy technique (3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy), Zubrod performance status (0 vs 1), and histology (squamous vs non-squamous). Patients are randomized to 1 of 4 treatment arms. (Arms II and IV closed to accrual effective 6/17/11)

Patients may undergo tumor tissue, blood, and urine collection periodically during study for tissue banking or biomarker correlative studies.

Patients may undergo quality-of-life assessment at baseline and periodically during study.

After completion of study therapy, patients are followed periodically for 5 years and then annually thereafter.

Conditions

Lung Cancer; Radiation Toxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

60 Gy RT

60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Group Type: ACTIVE_COMPARATOR

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

60 Gy RT

Intervention Type: RADIATION

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.

74 Gy RT

74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

74 Gy RT

Intervention Type: RADIATION

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.

60 Gy RT + Cetuximab

60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: BIOLOGICAL

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.

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

60 Gy RT

Intervention Type: RADIATION

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.

74 Gy RT + Cetuximab

74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: BIOLOGICAL

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.

Carboplatin

Intervention Type: DRUG

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.

Paclitaxel

Intervention Type: DRUG

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.

74 Gy RT

Intervention Type: RADIATION

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.

Interventions

Cetuximab

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.

Intervention Type: BIOLOGICAL

Carboplatin

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.

Intervention Type: DRUG

Paclitaxel

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.

Intervention Type: DRUG

60 Gy RT

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 30 fractions over the course of 6 weeks.

Intervention Type: RADIATION

74 Gy RT

Radiation therapy (RT) in once-daily, 2 Gy fractions, given in 37 fractions over the course of 7.5 weeks.

Intervention Type: RADIATION

Other Intervention Names

Erbitux; Paraplatin; Taxol; Abraxane; RT

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. 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.

4. If a pleural effusion is present, the following criteria must be met to exclude malignant involvement (incurable T4 disease):

• When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
• Exudative pleural effusions are excluded, regardless of cytology;
• Effusions that are minimal (i.e. not visible on chest x-ray) that are too small to safely tap are eligible.

5. Patients must have measurable or evaluable disease.

6. Patients with post-obstructive pneumonia are eligible.

7. Patients must be at least 3 weeks from prior thoracotomy (if performed).

8. Zubrod Performance Status 0-1;

9. Age ≥ 18;

10. Pulmonary function tests (PFTs) including forced expiratory volume in one second (FEV1) within 12 weeks prior to registration; for FEV1, the best value obtained pre- or post bronchodilator must be ≥ 1.2 liters/second or ≥ 50% predicted.

11. Complete blood count (CBC)/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
• Platelets ≥ 100,000 cells/mm3;
• Hemoglobin ≥ 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.)

12. Serum creatinine within normal institutional limits or creatinine clearance ≥60 ml/min;

13. Bilirubin must be within or below normal institutional limits;

14. Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) < 2.5 x the institutional upper limit of normal (IULN);

15. Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria

1. N3 supraclavicular disease;

2. Greater than minimal, exudative, or cytologically positive pleural effusions;

3. Involved contralateral hilar nodes (i.e. greater than 1.5 cm on short axis or positive on PET scan);

4. ≥ 10% weight loss within the past month;

5. 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.

6. Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable.

7. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;

8. Prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway;

9. Prior severe infusion reaction to a monoclonal antibody;

10. 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;
• Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

11. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

12. Any history of allergic reaction to paclitaxel or other taxanes, or to carboplatin;

13. Uncontrolled neuropathy grade 2 or greater regardless of cause.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

North Central Cancer Treatment Group

NETWORK

Sponsor Role: collaborator

Cancer and Leukemia Group B

NETWORK

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffrey Bradley, MD

Role: PRINCIPAL_INVESTIGATOR

Mallinckrodt Institute of Radiology at Washington University Medical Center

Hak Choy, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Gregory A. Masters, MD

Role: STUDY_CHAIR

CCOP - Christiana Care Health Services

Steven E. Schild, MD

Role: STUDY_CHAIR

Mayo Clinic

Alex A. Adjei, MD, PhD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Jeffrey A. Bogart, MD

Role: STUDY_CHAIR

State University of New York - Upstate Medical University

Arthur William Blackstock, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Mark A. Socinski, MD

Role: STUDY_CHAIR

UNC Lineberger Comprehensive Cancer Center

George Blumenschein, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Ritsuko Komaki, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Jeff Sloan, PhD, HSR

Role: STUDY_CHAIR

Mayo Clinic

Mark Dobelbower, MD PhD

Role: STUDY_CHAIR

University of Alabama Medical Center

Tien Hoang, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Ken Forster, PhD

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center

Benjamin Movsas, MD

Role: STUDY_CHAIR

Henry Ford Hospital

Joe Y. Chang, MD PhD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Joseph O. Deasy, PhD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Arizona Oncology - Tucson

Tucson, Arizona, United States

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Enloe Cancer Center at Enloe Medical Center

Chico, California, United States

Cancer Care Center at John Muir Health - Concord Campus

Concord, California, United States

Saint Agnes Cancer Center at Saint Agnes Medical Center

Fresno, California, United States

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, United States

Memorial Medical Center

Modesto, California, United States

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Feather River Hospital Cancer Center

Paradise, California, United States

Radiation Oncology Center - Roseville

Roseville, California, United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Saint Helena Hospital

St. Helena, California, United States

Stanford Cancer Center

Stanford, California, United States

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

Poudre Valley Radiation Oncology

Fort Collins, Colorado, United States

North Suburban Medical Center

Thornton, Colorado, United States

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, United States

University of Florida Shands Cancer Center

Gainesville, Florida, United States

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, United States

Integrated Community Oncology Network at Southside Cancer Center

Jacksonville, Florida, United States

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Baptist Medical Center South

Jacksonville, Florida, United States

Integrated Community Oncology Network

Jacksonville Beach, Florida, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

Jupiter, Florida, United States

Baptist-South Miami Regional Cancer Program

Miami, Florida, United States

CCOP - Mount Sinai Medical Center

Miami Beach, Florida, United States

Integrated Community Oncology Network - Orange Park

Orange Park, Florida, United States

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, United States

Florida Cancer Center - Palatka

Palatka, Florida, United States

Sacred Heart Cancer Center at Sacred Heart Hospital

Pensacola, Florida, United States

Flagler Cancer Center

Saint Augustine, Florida, United States

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, United States

Emory Crawford Long Hospital

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Charles B. Eberhart Cancer Center at DeKalb Medical Center

Decatur, Georgia, United States

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Boise, Idaho, United States

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

University of Chicago Cancer Research Center

Chicago, Illinois, United States

Creticos Cancer Center at Advocate Illinois Masonic Medical Center

Chicago, Illinois, United States

Community Cancer Center

Normal, Illinois, United States

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF St. Francis Medical Center

Peoria, Illinois, United States

Radiation Oncology Associates Southwest

Fort Wayne, Indiana, United States

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, United States

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, United States

Central Indiana Cancer Centers - East

Indianapolis, Indiana, United States

Community Regional Cancer Care at Community Hospital East

Indianapolis, Indiana, United States

Community Regional Cancer Care at Community Hospital North

Indianapolis, Indiana, United States

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, United States

Mercy Regional Cancer Center at Mercy Medical Center

Cedar Rapids, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, United States

Central Baptist Hospital

Lexington, Kentucky, United States

Tulane Cancer Center Office of Clinical Research

Alexandria, Louisiana, United States

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, United States

CCOP - Ochsner

New Orleans, Louisiana, United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, United States

St. Agnes Hospital Cancer Center

Baltimore, Maryland, United States

Shore Regional Cancer Center at Memorial Hospital - Easton

Easton, Maryland, United States

Peninsula Regional Medical Center

Salisbury, Maryland, United States

Baystate Regional Cancer Program at D'Amour Center for Cancer Care

Springfield, Massachusetts, United States

Saint Joseph Mercy Cancer Center

Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, United States

Van Elslander Cancer Center at St. John Hospital and Medical Center

Grosse Pointe Woods, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

St. Mary Mercy Hospital

Livonia, Michigan, United States

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology Hematology, PA - Maplewood

Maplewood, Minnesota, United States

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital

Minneapolis, Minnesota, United States

Humphrey Cancer Center at North Memorial Outpatient Center

Robbinsdale, Minnesota, United States

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, United States

Regions Hospital Cancer Care Center

Saint Paul, Minnesota, United States

University of Mississippi Cancer Clinic

Jackson, Mississippi, United States

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, United States

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

City of Saint Peters, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

Barnes-Jewish West County Hospital

St Louis, Missouri, United States

Billings Clinic - Downtown

Billings, Montana, United States

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, United States

Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Methodist Estabrook Cancer Center

Omaha, Nebraska, United States

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Renown Institute for Cancer at Renown Regional Medical Center

Reno, Nevada, United States

Saint Mary's Regional Medical Center

Reno, Nevada, United States

Payson Center for Cancer Care at Concord Hospital

Concord, New Hampshire, United States

Center for Cancer Care at Exeter Hospital

Exeter, New Hampshire, United States

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, United States

UMDNJ University Hospital

Newark, New Jersey, United States

J. Phillip Citta Regional Cancer Center at Community Medical Center

Toms River, New Jersey, United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

New York Oncology Hematology, PC at Albany Regional Cancer Care

Albany, New York, United States

Veterans Affairs Medical Center - Albany

Albany, New York, United States

Sands Cancer Center

Canandaigua, New York, United States

St. Luke's - Roosevelt Hospital Center - St.Luke's Division

New York, New York, United States

Highland Hospital of Rochester

Rochester, New York, United States

University Radiation Oncology at Parkridge Hospital

Rochester, New York, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

SUNY Upstate Medical University Hospital

Syracuse, New York, United States

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, United States

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, United States

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, United States

Kinston Medical Specialists

Kinston, North Carolina, United States

FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center

Pinehurst, North Carolina, United States

Cancer Centers of North Carolina - Raleigh

Raleigh, North Carolina, United States

CCOP - MeritCare Hospital

Fargo, North Dakota, United States

Altru Cancer Center at Altru Hospital

Grand Forks, North Dakota, United States

Trinity CancerCare Center

Minot, North Dakota, United States

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, United States

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, United States

Barberton Citizens Hospital

Barberton, Ohio, United States

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, United States

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, United States

Cleveland Clinic Cancer Center

Independence, Ohio, United States

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, United States

Southwest General Health Center

Middleburg Heights, Ohio, United States

UHHS Chagrin Highlands Medical Center

Orange, Ohio, United States

St. Charles Mercy Hospital

Oregon, Ohio, United States

North Coast Cancer Care, Incorporated

Sandusky, Ohio, United States

Flower Hospital Cancer Center

Sylvania, Ohio, United States

St. Anne Mercy Hospital

Toledo, Ohio, United States

UHHS Westlake Medical Center

Westlake, Ohio, United States

Cleveland Clinic - Wooster

Wooster, Ohio, United States

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, United States

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, United States

Willamette Valley Cancer Center - Eugene

Eugene, Oregon, United States

Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

Allentown, Pennsylvania, United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Geisinger Cancer Institute at Geisinger Health

Danville, Pennsylvania, United States

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, United States

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Regional Cancer Center - Erie

Erie, Pennsylvania, United States

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Cancer Center of Paoli Memorial Hospital

Paoli, Pennsylvania, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Frankford Hospital Cancer Center - Torresdale Campus

Philadelphia, Pennsylvania, United States

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, United States

Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, United States

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Cancer Centers of the Carolinas - Faris Road

Greenville, South Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

Cancer Centers of the Carolinas - Seneca

Seneca, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Harrington Cancer Center

Amarillo, Texas, United States

Texas Oncology, PA at Texas Cancer Center - Arlington South

Arlington, Texas, United States

Texas Oncology, PA at Harris Center HEB

Bedford, Texas, United States

Texas Oncology, PA at Texas Cancer Center - Denton South

Denton, Texas, United States

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

Fort Worth, Texas, United States

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, United States

Longview Cancer Center

Longview, Texas, United States

West Texas Cancer Center

Odessa, Texas, United States

Cancer Care Centers of South Texas - Northeast

San Antonio, Texas, United States

Texas Oncology, PA at Texas Cancer Center - Sherman

Sherman, Texas, United States

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, United States

Tyler Cancer Center

Tyler, Texas, United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, United States

Utah Valley Regional Medical Center - Provo

Provo, Utah, United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, United States

Dixie Regional Medical Center - East Campus

St. George, Utah, United States

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, United States

University of Virginia Cancer Center

Charlottesville, Virginia, United States

CCOP - Virginia Mason Research Center

Seattle, Washington, United States

Cancer Care Northwest - Spokane South

Spokane, Washington, United States

Theda Care Cancer Institute

Appleton, Wisconsin, United States

Midelfort Clinic - Luther

Eau Claire, Wisconsin, United States

Luther Midlelfort Hospital

Eau Claire, Wisconsin, United States

Bellin Memorial Hospital

Green Bay, Wisconsin, United States

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, United States

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, United States

Gundersen Lutheran Center for Cancer and Blood

La Crosse, Wisconsin, United States

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, United States

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, United States

D.N. Greenwald Center

Mukwonago, Wisconsin, United States

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine, Wisconsin, United States

Door County Cancer Center at Door County Memorial Hospital

Sturgeon Bay, Wisconsin, United States

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, United States

Riverview UW Cancer Center at Riverview Hospital

Wisconsin Rapids, Wisconsin, United States

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Hopital Notre-Dame du CHUM

Montreal, Quebec, Canada

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, Canada

Saskatoon Cancer Centre at the University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

United States; Canada

References

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Reference Type: RESULT

PMID: 31841363 (View on PubMed)

Chun 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.

Reference Type: DERIVED

PMID: 38935373 (View on PubMed)

Zhang 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.

Reference Type: DERIVED

PMID: 36842666 (View on PubMed)

McWilliam 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.

Reference Type: DERIVED

PMID: 36738929 (View on PubMed)

McKenzie 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.

Reference Type: DERIVED

PMID: 36436615 (View on PubMed)

Movsas 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.

Reference Type: DERIVED

PMID: 26606200 (View on PubMed)

Bradley JD, Paulus R, Komaki R, Masters G, Blumenschein G, Schild S, Bogart J, Hu C, Forster K, Magliocco A, Kavadi V, Garces YI, Narayan S, Iyengar P, Robinson C, Wynn RB, Koprowski C, Meng J, Beitler J, Gaur R, Curran W Jr, Choy H. Standard-dose versus high-dose conformal radiotherapy with concurrent and consolidation carboplatin plus paclitaxel with or without cetuximab for patients with stage IIIA or IIIB non-small-cell lung cancer (RTOG 0617): a randomised, two-by-two factorial phase 3 study. Lancet Oncol. 2015 Feb;16(2):187-99. doi: 10.1016/S1470-2045(14)71207-0. Epub 2015 Jan 16.

Reference Type: DERIVED

PMID: 25601342 (View on PubMed)

Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Other Identifiers

CDR0000564240

Identifier Type: -

Identifier Source: secondary_id

NCCTG-N0628

Identifier Type: -

Identifier Source: secondary_id

CALGB-30609

Identifier Type: -

Identifier Source: secondary_id

NCI-2013-01762

Identifier Type: REGISTRY

Identifier Source: secondary_id

RTOG 0617

Identifier Type: -

Identifier Source: org_study_id