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Brief Title: Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
Official Title: A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)
Study ID: NCT00003364
Brief Summary: 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.
Detailed Description: 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Heatherwood Hospital, Ascot, England, United Kingdom
Royal Sussex County Hospital, Brighton, England, United Kingdom
Addenbrooke's NHS Trust, Cambridge, England, United Kingdom
Broomfield Hospital, Chelmsford, Essex, England, United Kingdom
Essex County Hospital, Colchester, England, United Kingdom
Royal Free Hospital, Hampstead, London, England, United Kingdom
Cookridge Hospital, Leeds, England, United Kingdom
Saint Bartholomew's Hospital, London, England, United Kingdom
Guy's and St. Thomas' Hospitals Trust, London, England, United Kingdom
Charing Cross Hospital, London, England, United Kingdom
Middlesex Hospital- Meyerstein Institute, London, England, United Kingdom
Mount Vernon Hospital, Northwood, England, United Kingdom
Peterborough Hospitals Trust, Peterborough, England, United Kingdom
Southend NHS Trust Hospital, Westcliff-On-Sea, England, United Kingdom
Name: Stephen G. Spiro
Affiliation: University College London Hospitals
Role: STUDY_CHAIR