Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Prophylactic Cranial Irradiation; Radiation Therapy
Intervention description: Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.; Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: extensive stage small cell lung cancer

Summary:

      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.
    

Eligibility criteria:

        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