Lung Cancer Clinical Trial
Official title:
A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. Combining more than one drug with radiation therapy may kill more tumor cells. The best
timing for radiation therapy and combination chemotherapy in treating limited stage small
cell lung cancer is not yet known .
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given
at different times along with combination chemotherapy in treating patients with limited
stage small cell lung cancer.
OBJECTIVES: I. Determine whether long term survival is affected by the timing of thoracic
radiotherapy in patients with limited stage small cell lung cancer who are receiving
combination chemotherapy. II. Determine whether the development of local recurrence and
distant metastases are affected by the timing of thoracic radiotherapy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. All
patients receive cyclophosphamide, doxorubicin, and vincristine by IV bolus alternating with
3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30
minutes. This treatment alternates every 3 weeks for six courses. Patients are randomized to
have thoracic radiotherapy either with course 2 (arm I) or with course 6 (arm II) of
chemotherapy. Patients in arm I are given 1 week of rest between radiotherapy and the second
course of chemotherapy. If there is no disease progression after chemotherapy and
locoregional irradiation, and a repeat brain scan is negative, patients receive prophylactic
brain irradiation. Patients are followed monthly for the first year and then every 2 months
thereafter.
PROJECTED ACCRUAL: This study will accrue 398 patients.
;
Allocation: Randomized, Primary Purpose: Treatment
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