Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
|ClinicalTrials.gov Identifier: NCT00003235|
Recruitment Status : Completed
First Posted : April 14, 2004
Last Update Posted : January 28, 2010
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. Combining more than one drug with either standard radiation therapy or radiation therapy given at different times may kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation therapy given at different times, in treating patients with stage III non-small cell lung cancer that cannot be surgically removed.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy||Phase 3|
OBJECTIVES: I. Determine response rates, duration of response, and survival of patients with unresectable or regionally advanced (M0) stage IIIA or IIIB non-small cell lung carcinoma treated with induction paclitaxel and carboplatin followed by conventional vs accelerated radiation. II. Evaluate the patterns of local and distant failure for patients treated with these regimens.
OUTLINE: Patients are stratified by histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and response to induction chemotherapy (initial response vs no response). All patients receive induction therapy consisting of paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats every 42 days for 2 courses. Patients whose disease has not progressed outside the thorax are then randomized to 1 of 2 treatment arms. Arm I: Patients receive standard radiotherapy once a day, 5 days a week for 6-7 weeks. Arm II: Patients receive hyperfractionated accelerated radiotherapy 3 times daily, 5 days a week over 2.5 weeks. Each fraction is separated by a minimum of 4 hours. Radiotherapy begins between days 43 and 50. Patients are followed at 1 month after radiotherapy, then every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter.
PROJECTED ACCRUAL: Approximately 294 patients will be accrued for this study within 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||294 participants|
|Official Title:||A Phase III Trial of Induction Paclitaxel and Carboplatin Followed By Standard Radiotherapy (64 Gy/7 Weeks) vs. Hyperfractionated Accelerated Radiotherapy (HART 57.6 Gy/2.5 Weeks) For Patients With Unresectable Stage IIIA and IIIB Non-Small Cell Lung Cancer|
|Study Start Date :||April 1998|
|Actual Primary Completion Date :||August 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003235
|United States, New Jersey|
|Trinitas Hospital - Jersey Street Campus|
|Elizabeth, New Jersey, United States, 07201|
|Summit, New Jersey, United States, 07902-0220|
|Community Medical Center|
|Toms River, New Jersey, United States, 08755|
|St. Francis Medical Center|
|Trenton, New Jersey, United States, 08629|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Study Chair:||Chandra P. Belani, MD||University of Pittsburgh|