Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy in treating patients with non-small cell lung cancer that cannot be surgically removed.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PHASE I/II DOSE ESCALATION STUDY USING THREE DIMENSIONAL CONFORMAL RADIATION THERAPY POST INDUCTION CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED INOPERABLE, NON-SMALL CELL LUNG CANCER|
|Study Start Date:||July 1995|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Assess the treatment related morbidity associated with escalating doses of 3-dimensional conformal radiotherapy (3D-CRT) in patients with locally advanced, inoperable, non-small cell lung cancer. II. Determine the maximum tolerated dose of 3D-CRT in these patients. III. Evaluate the morbidity associated with high dose 3D-CRT for carcinoma of the lung.
OUTLINE: This is a dose escalation study. Patients are stratified by the percentage of total lung volume (TLV) receiving greater than 20 Gy of radiation (less than 25% vs 25% to less than 37% vs at least 37%). As of 7/1/1999, the third stratum closed to accrual. Patients receive 3-dimensional conformal radiotherapy (3D-CRT) 5 days a week for either 6-7 weeks, 7-8 weeks, or 9-10 weeks (depending on the cohort). Within each TLV stratum, cohorts of 15-36 patients receive escalating doses of 3D-CRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which less than 15% of patients experience dose limiting toxicity. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-36 patients per cohort will be accrued for this study within 1 year. As of 7/1/1999, the third stratum closed to accrual.