A Randomised Study of Timing of Thoracic Irradiation in Small Cell Lung Cancer (Study 8)
N/A
74 Years
Both
Lung Cancer
Trial Information
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.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed limited stage small cell lung cancer
Limited disease defined as within the hemithorax, mediastinum, or ipsilateral
supraclavicular nodes No evidence of extensive disease (i.e., contralateral lung or
contralateral supraclavicular nodes) No metastatic disease Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: Under 75 Performance status: ECOG 0-3 Life expectancy: At
least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine normal OR Creatinine
clearance greater than 50 mL/min OR Pentetic acid/ethylenediaminetetraacetic acid
clearance greater than 70 mL/min Cardiovascular: No myocardial infarction in the 3 months
prior to diagnosis No pericardial effusion Pulmonary: No pleural effusion seen on chest
x-ray Pleural effusion identified on CT allowed, if not visible on chest x-ray Other: No
medical condition that excludes the use of chemotherapy or thoracic irradiation Must be
able to tolerate the prescribed study radiotherapy No other malignant tumor for at least 3
years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent prednisone or other
corticosteroids for hypercalcemia allowed Radiotherapy: No prior radiotherapy Surgery: Not
specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Stephen G. Spiro
Investigator Role:
Study Chair
Investigator Affiliation:
University College London Hospitals
Authority:
United States: Federal Government
Study ID:
CDR0000066349
NCT ID:
NCT00003364
Start Date:
January 1993
Completion Date:
Related Keywords:
- Lung Cancer
- limited stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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