Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer
18 Years
75 Years
Both
Lung Cancer
Trial Information
Prophylactic Cranial Irradiation In Extensive Disease Small Cell Lung Cancer
OBJECTIVES:
- Compare the incidence of, and time to, symptomatic brain metastases in patients with
previously treated extensive stage small cell lung cancer treated with prophylactic
cranial irradiation vs no further therapy.
- Compare the quality of life and survival of these patients.
- Determine the toxicity of this regimen in these patients.
- Determine the health economics associated with this study.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center and performance status. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Within 5 weeks after completion of prior chemotherapy, patients undergo
prophylactic cranial irradiation once daily for 5-12 days.
- Arm II: Patients receive no further therapy after completion of prior chemotherapy.
Quality of life is assessed at baseline, 6 weeks, every 3 months for 1 year, and then every
6 months thereafter.
Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months
thereafter.
PROJECTED ACCRUAL: A total of 287 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Cytologically or histologically confirmed small cell lung cancer
- Documented extensive disease before the initiation of chemotherapy
- Responsive disease after 4 to 6 courses of initial chemotherapy
- No more than 5 weeks since completion of prior chemotherapy
- No brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 75
Performance status:
- WHO 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No other prior or concurrent malignancy except skin cancer or carcinoma in situ of
the cervix
- No psychological, familial, sociological, or geographical condition that would
preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- No prior radiotherapy to the brain
- No prior radiotherapy to the head and neck
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Time to symptomatic brain metastases measured by Logrank at 6 weeks, every 3 months in year 1, and then every 6 months
Safety Issue:
No
Principal Investigator
B.J. Slotman, PhD, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Free University Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-22993-08993
NCT ID:
NCT00016211
Start Date:
February 2001
Completion Date:
Related Keywords:
- Lung Cancer
- extensive stage small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
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