A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)
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.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Stephen G. Spiro
Study Chair
University College London Hospitals
United States: Federal Government
CDR0000066349
NCT00003364
January 1993
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