Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00003387
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving chemotherapy before combined chemotherapy and radiation therapy is more effective than combined chemotherapy and radiation therapy alone in treating patients with non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel followed by radiation therapy and chemotherapy with radiation therapy and chemotherapy alone in treating patients with stage III non-small cell lung cancer that cannot be removed during surgery.
- Detailed Description
OBJECTIVES: I. Compare the effects of concurrent chemoradiotherapy utilizing carboplatin and paclitaxel with or without prior induction chemotherapy on overall response rate, disease-free survival, and overall survival in patients with unresectable stage III non-small cell lung cancer. II. Compare the effects of these treatments on locoregional vs distant failure in these patients. III. Compare the toxicity of these treatments in these patients.
OUTLINE: This is a randomized study. Patients are stratified by measurable vs evaluable disease. Patients are randomized to 1 of 2 treatment arms: Arm I (immediate concurrent chemoradiotherapy): Patients receive IV paclitaxel over 1 hour followed by IV carboplatin over 30 minutes on day 1, and radiation therapy to the chest 5 times a week beginning on day 1. Treatment repeats weekly for a total of 7 courses. Arm II (induction chemotherapy followed by delayed concurrent chemoradiotherapy): Patients receive IV paclitaxel over 3 hours followed by IV carboplatin over 30 minutes; treatment repeats every 3 weeks for 2 courses. Patients then receive 7 courses of concurrent chemoradiotherapy as in Arm I. Total treatment time is 13 weeks. Patients are followed every 2 months for 2 years, then every 4 months for the next 2 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 366
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chemo + radiation chemotherapy - Chemo + radiation radiation therapy - Induction chemo + chemo & radiation chemotherapy - Induction chemo + chemo & radiation radiation therapy - Chemo + radiation paclitaxel - Induction chemo + chemo & radiation paclitaxel - Chemo + radiation carboplatin - Induction chemo + chemo & radiation carboplatin -
- Primary Outcome Measures
Name Time Method overall response rate Up to 5 years overall survival Up to 5 years disease-free survival Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Howard University Cancer Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
🇺🇸Chicago, Illinois, United States
Hematology Oncology Associates of the Quad Cities
🇺🇸Bettendorf, Iowa, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
🇺🇸Columbia, Missouri, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
Cooper Cancer Institute
🇺🇸Camden, New Jersey, United States
Veterans Affairs Medical Center - Buffalo
🇺🇸Buffalo, New York, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Syracuse
🇺🇸Syracuse, New York, United States
Veterans Affairs Medical Center - Memphis
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - San Francisco
🇺🇸San Francisco, California, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
Veterans Affairs Medical Center - Durham
🇺🇸Durham, North Carolina, United States
Veterans Affairs Medical Center - Minneapolis
🇺🇸Minneapolis, Minnesota, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Veterans Affairs Medical Center - Togus
🇺🇸Togus, Maine, United States
Veterans Affairs Medical Center - White River Junction
🇺🇸White River Junction, Vermont, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Veterans Affairs Medical Center - Birmingham
🇺🇸Birmingham, Alabama, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Veterans Affairs Medical Center - Richmond
🇺🇸Richmond, Virginia, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States