Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

OBJECTIVES:

Primary

- To compare the 1-year overall median survival rate in patients with extensive stage
small cell lung cancer treated with prophylactic cranial irradiation with vs without
consolidative extracranial radiotherapy following platinum-based chemotherapy.

Secondary

- To compare treatment-related adverse events in these patients.

- To evaluate patterns of failure in these patients.

- To compare the time to first failure in these patients.

- To evaluate the percentage of the planned radiotherapy dose given to each site.

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.

- Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.

- Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also
undergo consolidative extracranial radiotherapy to locoregional and residual metastatic
disease 5 days per week for 2-3 weeks.

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 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment
with chemotherapy

- Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND
meets the following criteria:

- Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease
according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if
radiotherapy has been delivered to primary disease with chemotherapy, there must
be complete or partial response in ≥ 1 of the sites that has not been treated
with radiotherapy)

- No progression in any site

- 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:

- Acute bacterial or fungal infection requiring IV antibiotics at the time of study
registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of study
registration

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy
and alopecia])

- Thoracic radiotherapy administered concurrently with or before chemotherapy for the
current diagnosis allowed (these patients will not receive mediastinal radiotherapy
per protocol)

- No prior radiotherapy to the region of this cancer that would result in overlap of
radiotherapy fields

- No concurrent chemotherapy