Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months*
Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria:
No limited stage SCLC, even if disease progressed
No brain or central nervous system (CNS) metastases
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
Absolute neutrophil count (ANC) ≥ 1,000/mm^3
Platelets ≥ 75,000/mm^3
Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)
Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)
Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the liver)
Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the kidneys)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No severe, active co-morbidity, defined as any of the following:
PRIOR CONCURRENT THERAPY:
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Hartford, Connecticut 06105, United States
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