Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
RATIONALE: Amifostine may be an effective treatment for the toxic side effects caused by radiation therapy and chemotherapy. It is not yet known whether chemotherapy and radiation therapy are more effective with or without amifostine for non-small cell lung cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of amifostine in treating patients who have stage II or stage III non-small cell lung cancer that cannot be surgically removed and who are undergoing chemotherapy and radiation therapy.
Drug/Agent Toxicity by Tissue/Organ
Drug: amifostine trihydrate
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Phase III Randomized Study of Amifostine Mucosal Protection for Patients With Favorable Performance Inoperable Stage II-III A/B Non-Small Cell Lung Cancer (NSCLC) Receiving Sequential Induction and Concurrent Hyperfractionated Radiotherapy With Paclitaxel and Carboplatin|
|Study Start Date:||September 1998|
|Primary Completion Date:||July 2002 (Final data collection date for primary outcome measure)|
Experimental: Arm 1
Radiation therapy and chemotherapy + Amifostine
|Biological: filgrastim Drug: amifostine trihydrate Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy|
Active Comparator: Arm 2
Radiation therapy and chemotherapy alone
|Biological: filgrastim Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy|
OBJECTIVES: I. Evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of non-hematologic toxicity, specifically esophagitis and pneumonitis, during concurrent hyperfractionated radiotherapy and chemotherapy (with paclitaxel and carboplatin) in patients with stage II, IIIA, or IIIB non-small cell lung cancer. II. Evaluate the differences in quality of life and symptom distress, specifically dysphagia, between patients receiving amifostine and those not receiving amifostine. III. Evaluate the relationship of tobacco use and alcohol use during treatment to appraisals of quality of life and symptom distress, specifically esophagitis, in the two groups. IV. Evaluate the efficacy of induction therapy with paclitaxel and carboplatin followed by concurrent chemotherapy and hyperfractionated radiotherapy in these patients.
OUTLINE: This is an open-label treatment and randomized supportive care study. Patients are stratified according to disease stage (II vs IIIA vs IIIB), Karnofsky performance status (90-100% vs 70-80%), and age (70 and under vs over 70). Patients are randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours on days 1 and 22 and over 1 hour weekly for 6 weeks beginning on day 43. Patients receive carboplatin IV over 30 minutes immediately after each paclitaxel dose. Patients receive filgrastim (G-CSF) subcutaneously for 10-14 days after each of the first two paclitaxel and carboplatin doses. Radiotherapy begins on day 43 and is administered twice daily for 5 days per week for 6 weeks. Beginning on day 43, patients receive amifostine IV over 5-7 minutes 4 days a week for 6 weeks. Arm II: Patients receive treatment as in arm I without amifostine. Quality of life is assessed at baseline, before chemoradiation (after 2 courses of induction chemotherapy), the last week of chemoradiation (week 6), and at the 6-week follow-up visit. Patients are followed at 1 month, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 244 patients (122 per treatment arm) will be accrued for this study within 38 months.