Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Registration Number
- NCT00003317
- 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. Combining more than one drug may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy for stage IIIA non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without radiation therapy in treating patients who have stage IIIA non-small cell lung cancer that has been surgically removed.
- Detailed Description
OBJECTIVES: I. Compare the overall survival of surgically resected patients with limited stage IIIA non-small cell lung cancer who are treated by postoperative chemotherapy with or without adjuvant radiotherapy. II. Compare failure free survival of these patients. III. Describe the patterns of local and distant recurrence in these patients. IV. Determine the toxicities associated with chemotherapy with or without adjuvant radiotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are randomized into one of two treatment arms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery + paclitaxel + carboplatin + radiotherapy radiation therapy Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Surgery + paclitaxel + carboplatin surgery Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Surgery + paclitaxel + carboplatin + radiotherapy surgery Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Surgery + paclitaxel + carboplatin carboplatin Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Surgery + paclitaxel + carboplatin paclitaxel Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Surgery + paclitaxel + carboplatin + radiotherapy carboplatin Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter. Surgery + paclitaxel + carboplatin + radiotherapy paclitaxel Four to eight weeks after surgery, all patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on days 1, 22, 43, and 64. Following completion of four courses of chemotherapy, patients receive radiotherapy 5 days a week for 5 weeks to the mediastinum, beginning 2.5 to 4 weeks after completion of chemotherapy. Patients are followed at least every 4 months for 2 years, then every 6 months thereafter.
- Primary Outcome Measures
Name Time Method Disease-free survival Up to 5 years Overall survival Up to 5 years Patterns of local and distant recurrence in these patients Up to 5 years Toxicities associated with chemotherapy with or without adjuvant radiotherapy in patients. Up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Quain & Ramstad Clinic, P.C.
🇺🇸Bismarck, North Dakota, United States
CCOP - Scottsdale Oncology Program
🇺🇸Scottsdale, Arizona, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
CCOP - Cedar Rapids Oncology Project
🇺🇸Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
CCOP - Toledo Community Hospital Oncology Program
🇺🇸Toledo, Ohio, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Altru Health Systems
🇺🇸Grand Forks, North Dakota, United States
CCOP - Merit Care Hospital
🇺🇸Fargo, North Dakota, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Siouxland Hematology-Oncology
🇺🇸Sioux City, Iowa, United States
CCOP - Sioux Community Cancer Consortium
🇺🇸Sioux Falls, South Dakota, United States