Clinical trial NCT00533949: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Radiation Toxicity
Keywords: radiation toxicity
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: North Central Cancer Treatment Group
name: Cancer and Leukemia Group B
name: NRG Oncology
First posted: 2007-09-24
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study was revised 06/18/08 to a 2x2 factorial design to evaluate the addition of cetuximab to the radiation therapy regimens.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Survival
timeFrame: 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:
measure: Progression-free Survival
timeFrame: 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.
measure: Local-regional Failure (Reported as Two-year Estimates)
timeFrame: 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.
measure: 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
timeFrame: 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.
measure: Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0
timeFrame: 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.
measure: Death During or Within 30 Days of Discontinuation of Protocol Treatment
timeFrame: From start of protocol treatment to 24 months.
measure: Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).
timeFrame: At baseline and 3 months.
measure: Patient-reported Swallowing Score (Area Under the Curve)
timeFrame: From randomization to 6 weeks after start of radiation therapy (6-10 weeks from randomization)
measure: EuroQoL (EQ5D) Visual Analog Scale (VAS) Through One Year (Area Under the Curve)
timeFrame: From randomization to one year
measure: Overall Survival and Local-regional Failure by Epithelial Growth Factor Receptor (EGFR) Group
timeFrame: 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.
measure: Percentage of Patients With Grade 3+ Adverse Events by Epithelial Growth Factor Receptor (EGFR) Group
timeFrame: 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.
measure: Prognostic and Predictive Effects of Gross Tumor Volume (GTV) on Overall Survival
timeFrame: 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.
measure: Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure
timeFrame: 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.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Comprehensive Cancer Center
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology - Tucson
state: Arizona
city: Carmichael
country: United States
facility: Mercy Cancer Center at Mercy San Juan Medical Center
state: California
city: Chico
country: United States
facility: Enloe Cancer Center at Enloe Medical Center
state: California
city: Concord
country: United States
facility: Cancer Care Center at John Muir Health - Concord Campus
state: California
city: Fresno
country: United States
facility: Saint Agnes Cancer Center at Saint Agnes Medical Center
state: California
city: La Jolla
country: United States
facility: Rebecca and John Moores UCSD Cancer Center
state: California
city: Modesto
country: United States
facility: Memorial Medical Center
state: California
city: Orange
country: United States
facility: St. Joseph Hospital Regional Cancer Center - Orange
state: California
city: Paradise
country: United States
facility: Feather River Hospital Cancer Center
state: California
city: Roseville
country: United States
facility: Radiation Oncology Center - Roseville
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento Medical Group, Incorporated
state: California
city: Sacramento
country: United States
facility: University of California Davis Cancer Center
state: California
city: Saint Helena
country: United States
facility: Saint Helena Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center at Penrose Hospital
state: Colorado
city: Englewood
country: United States
facility: Swedish Medical Center
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Radiation Oncology
state: Colorado
city: Thornton
country: United States
facility: North Suburban Medical Center
state: Colorado
city: Newark
country: United States
facility: CCOP - Christiana Care Health Services
state: Delaware
city: Washington
country: United States
facility: Washington Cancer Institute at Washington Hospital Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center Cancer Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida Shands Cancer Center
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute at Memorial Regional Hospital
state: Florida
city: Jacksonville Beach
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Jacksonville
country: United States
facility: Baptist Cancer Institute - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network at Southside Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center South
state: Florida
city: Jupiter
country: United States
facility: Ella Milbank Foshay Cancer Center at Jupiter Medical Center
state: Florida
city: Miami Beach
country: United States
facility: CCOP - Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist-South Miami Regional Cancer Program
state: Florida
city: Orange Park
country: United States
facility: Integrated Community Oncology Network - Orange Park
state: Florida
city: Orlando
country: United States
facility: M.D. Anderson Cancer Center at Orlando
state: Florida
city: Palatka
country: United States
facility: Florida Cancer Center - Palatka
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Cancer Center at Sacred Heart Hospital
state: Florida
city: Saint Augustine
country: United States
facility: Flagler Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Center for Excellence at Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Decatur
country: United States
facility: Charles B. Eberhart Cancer Center at DeKalb Medical Center
state: Georgia
city: Boise
country: United States
facility: Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
state: Idaho
city: Boise
country: United States
facility: Mountain States Tumor Institute at St. Luke's Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
city: Chicago
country: United States
facility: Creticos Cancer Center at Advocate Illinois Masonic Medical Center
state: Illinois
city: Normal
country: United States
facility: Community Cancer Center
state: Illinois
city: Pekin
country: United States
facility: Cancer Treatment Center at Pekin Hospital
state: Illinois
city: Peoria
country: United States
facility: Methodist Medical Center of Illinois
state: Illinois
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
city: Fort Wayne
country: United States
facility: Radiation Oncology Associates Southwest
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Regional Cancer Center at Parkview Health
state: Indiana
city: Goshen
country: United States
facility: Center for Cancer Care at Goshen General Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers - East
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Care at Community Hospital East
state: Indiana
city: Indianapolis
country: United States
facility: Community Regional Cancer Care at Community Hospital North
state: Indiana
city: Muncie
country: United States
facility: Cancer Center at Ball Memorial Hospital
state: Indiana
city: Cedar Rapids
country: United States
facility: Mercy Regional Cancer Center at Mercy Medical Center
state: Iowa
city: Des Moines
country: United States
facility: John Stoddard Cancer Center at Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mercy Cancer Center at Mercy Medical Center - Des Moines
state: Iowa
city: Mason City
country: United States
facility: Mercy Cancer Center at Mercy Medical Center - North Iowa
state: Iowa
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Alexandria
country: United States
facility: Tulane Cancer Center Office of Clinical Research
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center - Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: MBCCOP - LSU Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: CCOP - Ochsner
state: Louisiana
city: Baltimore
country: United States
facility: Greenebaum Cancer Center at University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: St. Agnes Hospital Cancer Center
state: Maryland
city: Easton
country: United States
facility: Shore Regional Cancer Center at Memorial Hospital - Easton
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Springfield
country: United States
facility: Baystate Regional Cancer Program at D'Amour Center for Cancer Care
state: Massachusetts
city: Ann Arbor
country: United States
facility: Saint Joseph Mercy Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Lacks Cancer Center at Saint Mary's Health Care
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Van Elslander Cancer Center at St. John Hospital and Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Livonia
country: United States
facility: St. Mary Mercy Hospital
state: Michigan
city: Port Huron
country: United States
facility: Mercy Regional Cancer Center at Mercy Hospital
state: Michigan
city: Burnsville
country: United States
facility: Fairview Ridges Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology, PA - Maplewood
state: Minnesota
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
state: Minnesota
city: Robbinsdale
country: United States
facility: Humphrey Cancer Center at North Memorial Outpatient Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Saint Cloud
country: United States
facility: CentraCare Clinic - River Campus
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital Cancer Care Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Cancer Clinic
state: Mississippi
city: Pascagoula
country: United States
facility: Regional Cancer Center at Singing River Hospital
state: Mississippi
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish West County Hospital
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
state: Missouri
city: Billings
country: United States
facility: Billings Clinic - Downtown
state: Montana
city: Kearney
country: United States
facility: Good Samaritan Cancer Center at Good Samaritan Hospital
state: Nebraska
city: Lincoln
country: United States
facility: Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Methodist Estabrook Cancer Center
state: Nebraska
city: Las Vegas
country: United States
facility: CCOP - Nevada Cancer Research Foundation
state: Nevada
city: Reno
country: United States
facility: Renown Institute for Cancer at Renown Regional Medical Center
state: Nevada
city: Reno
country: United States
facility: Saint Mary's Regional Medical Center
state: Nevada
city: Concord
country: United States
facility: Payson Center for Cancer Care at Concord Hospital
state: New Hampshire
city: Exeter
country: United States
facility: Center for Cancer Care at Exeter Hospital
state: New Hampshire
city: Manchester
country: United States
facility: Elliot Regional Cancer Center at Elliot Hospital
state: New Hampshire
city: Marlton
country: United States
facility: Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
state: New Jersey
city: Newark
country: United States
facility: UMDNJ University Hospital
state: New Jersey
city: Toms River
country: United States
facility: J. Phillip Citta Regional Cancer Center at Community Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Cancer Institute of New Jersey at Cooper - Voorhees
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Center
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, PC at Albany Regional Cancer Care
state: New York
city: Albany
country: United States
facility: Veterans Affairs Medical Center - Albany
state: New York
city: Canandaigua
country: United States
facility: Sands Cancer Center
state: New York
city: New York
country: United States
facility: St. Luke's - Roosevelt Hospital Center - St.Luke's Division
state: New York
city: Rochester
country: United States
facility: Highland Hospital of Rochester
state: New York
city: Rochester
country: United States
facility: University Radiation Oncology at Parkridge Hospital
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center at University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Hospital
state: New York
city: Burlington
country: United States
facility: Alamance Cancer Center at Alamance Regional Medical Center
state: North Carolina
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Blumenthal Cancer Center at Carolinas Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Presbyterian Cancer Center at Presbyterian Hospital
state: North Carolina
city: Kinston
country: United States
facility: Kinston Medical Specialists
state: North Carolina
city: Pinehurst
country: United States
facility: FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
state: North Carolina
city: Raleigh
country: United States
facility: Cancer Centers of North Carolina - Raleigh
state: North Carolina
city: Fargo
country: United States
facility: CCOP - MeritCare Hospital
state: North Dakota
city: Grand Forks
country: United States
facility: Altru Cancer Center at Altru Hospital
state: North Dakota
city: Minot
country: United States
facility: Trinity CancerCare Center
state: North Dakota
city: Akron
country: United States
facility: McDowell Cancer Center at Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Summa Center for Cancer Care at Akron City Hospital
state: Ohio
city: Barberton
country: United States
facility: Barberton Citizens Hospital
state: Ohio
city: Canton
country: United States
facility: Aultman Cancer Center at Aultman Hospital
state: Ohio
city: Chillicothe
country: United States
facility: Adena Regional Medical Center
state: Ohio
city: Cincinnati
country: United States
facility: Charles M. Barrett Cancer Center at University Hospital
state: Ohio
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cancer Center at Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital Cancer Care
state: Ohio
city: Independence
country: United States
facility: Cleveland Clinic Cancer Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Cancer Center at Hillcrest Hospital
state: Ohio
city: Middleburg Heights
country: United States
facility: Southwest General Health Center
state: Ohio
city: Orange Village
country: United States
facility: UHHS Chagrin Highlands Medical Center
state: Ohio
city: Oregon
country: United States
facility: St. Charles Mercy Hospital
state: Ohio
city: Sandusky
country: United States
facility: North Coast Cancer Care, Incorporated
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital Cancer Center
state: Ohio
city: Toledo
country: United States
facility: St. Anne Mercy Hospital
state: Ohio
city: Westlake
country: United States
facility: UHHS Westlake Medical Center
state: Ohio
city: Wooster
country: United States
facility: Cleveland Clinic - Wooster
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma University Cancer Institute
state: Oklahoma
city: Tulsa
country: United States
facility: Natalie Warren Bryant Cancer Center at St. Francis Hospital
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Center - Eugene
state: Oregon
city: Allentown
country: United States
facility: Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Cancer Institute at Geisinger Health
state: Pennsylvania
city: Dunmore
country: United States
facility: Northeast Radiation Oncology Center
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Dale and Frances Hughes Cancer Center at Pocono Medical Center
state: Pennsylvania
city: Erie
country: United States
facility: Regional Cancer Center - Erie
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
state: Pennsylvania
city: Paoli
country: United States
facility: Cancer Center of Paoli Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Frankford Hospital Cancer Center - Torresdale Campus
state: Pennsylvania
city: Philadelphia
country: United States
facility: Albert Einstein Cancer Center
state: Pennsylvania
city: Reading
country: United States
facility: McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Cancer Center at Lankenau Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center at Medical University of South Carolina
state: South Carolina
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas - Faris Road
state: South Carolina
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Seneca
country: United States
facility: Cancer Centers of the Carolinas - Seneca
state: South Carolina
city: Spartanburg
country: United States
facility: Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Cancer Center at Sanford USD Medical Center
state: South Dakota
city: Kingsport
country: United States
facility: Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Harrington Cancer Center
state: Texas
city: Arlington
country: United States
facility: Texas Oncology, PA at Texas Cancer Center - Arlington South
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, PA at Harris Center HEB
state: Texas
city: Denton
country: United States
facility: Texas Oncology, PA at Texas Cancer Center - Denton South
state: Texas
city: Fort Worth
country: United States
facility: Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
state: Texas
city: Houston
country: United States
facility: M. D. Anderson Cancer Center at University of Texas
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas - Northeast
state: Texas
city: Sherman
country: United States
facility: Texas Oncology, PA at Texas Cancer Center - Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Murray
country: United States
facility: Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Regional Medical Center - Provo
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center - East Campus
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists at UCS Cancer Center
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care - University Health Center Campus
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Seattle
country: United States
facility: CCOP - Virginia Mason Research Center
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest - Spokane South
state: Washington
city: Appleton
country: United States
facility: Theda Care Cancer Institute
state: Wisconsin
city: Eau Claire
country: United States
facility: Midelfort Clinic - Luther
state: Wisconsin
city: Eau Claire
country: United States
facility: Luther Midlelfort Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Bellin Memorial Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: St. Mary's Hospital Medical Center - Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: St. Vincent Hospital Regional Cancer Center
state: Wisconsin
city: La Crosse
country: United States
facility: Gundersen Lutheran Center for Cancer and Blood
state: Wisconsin
city: Marinette
country: United States
facility: Bay Area Cancer Care Center at Bay Area Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Veterans Affairs Medical Center - Milwaukee
state: Wisconsin
city: Mukwonago
country: United States
facility: D.N. Greenwald Center
state: Wisconsin
city: Racine
country: United States
facility: All Saints Cancer Center at Wheaton Franciscan Healthcare
state: Wisconsin
city: Sturgeon Bay
country: United States
facility: Door County Cancer Center at Door County Memorial Hospital
state: Wisconsin
city: Waukesha
country: United States
facility: Waukesha Memorial Hospital Regional Cancer Center
state: Wisconsin
city: Wisconsin Rapids
country: United States
facility: Riverview UW Cancer Center at Riverview Hospital
state: Wisconsin
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre at Pasqua Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre at the University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Mallinckrodt Institute of Radiology at Washington University Medical Center
name: Jeffrey Bradley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Simmons Cancer Center
name: Hak Choy, MD
role: STUDY_CHAIR
affiliation: CCOP - Christiana Care Health Services
name: Gregory A. Masters, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Steven E. Schild, MD
role: STUDY_CHAIR
affiliation: Roswell Park Cancer Institute
name: Alex A. Adjei, MD, PhD
role: STUDY_CHAIR
affiliation: State University of New York - Upstate Medical University
name: Jeffrey A. Bogart, MD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Arthur William Blackstock, MD
role: STUDY_CHAIR
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Mark A. Socinski, MD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: George Blumenschein, MD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Ritsuko Komaki, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Jeff Sloan, PhD, HSR
role: STUDY_CHAIR
affiliation: University of Alabama Medical Center
name: Mark Dobelbower, MD PhD
role: STUDY_CHAIR
affiliation: University of Wisconsin, Madison
name: Tien Hoang, MD
role: STUDY_CHAIR
affiliation: H. Lee Moffitt Cancer Center
name: Ken Forster, PhD
role: STUDY_CHAIR
affiliation: Henry Ford Hospital
name: Benjamin Movsas, MD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Joe Y. Chang, MD PhD
role: STUDY_CHAIR
affiliation: Memorial Sloan Kettering Cancer Center
name: Joseph O. Deasy, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.