Trial Information

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

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.