Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Prophylactic cranial irradiation, 2.5 Gy fx; Prophylactic cranial irradiation, 2.0 Gy fx; Prophylactic cranial irradiation, 1.5 Gy fx
Intervention description: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy; Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy; Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 265.0
Sex: All
Maximum age: 120 Years
Healthy volunteers: No
Keywords: limited stage small cell lung cancer

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
      known which radiation therapy regimen is more effective in preventing brain metastases in
      patients with limited-stage small cell lung cancer while taking into account chronic
      neurotoxicity from radiation therapy.

      PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity
      between three different brain irradiation regimens. The corresponding phase III component
      addressing the prevention of brain metastases was run by EORTC and reported separately
      (NCT00005062).
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed small cell lung cancer by fine needle
             aspiration, biopsy, or 2 positive sputa

               -  Limited stage (I-IIIB)

                    -  Confined to 1 hemithorax

                    -  No T4 based on malignant pleural effusion, or N3 disease based on
                       contralateral hilar or contralateral supraclavicular involvement

          -  Complete response after induction chemotherapy (with or without thoracic radiotherapy)

          -  Consolidative chest radiotherapy may be initiated before study

          -  No radiographic evidence of any of the following:

               -  Brain metastases

                    -  Normal brain CT scan or MRI less than 1 month before study

               -  Ipsilateral lung metastases

               -  Malignant pleural effusion

                    -  Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

        PATIENT CHARACTERISTICS:

        Age

          -  Not specified

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute granulocyte count at least 1,500/mm^3

          -  Platelet count at least 75,000/mm^3

          -  Hemoglobin at least 10.0 g/dL^

        Hepatic

          -  Not specified

        Renal

          -  Not specified

        Pulmonary

          -  See Disease Characteristics

        Other

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Neurological function class 1 or 2

          -  No epilepsy requiring permanent oral medication

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No other serious medical or psychiatric condition that would preclude study
             participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  See Disease Characteristics

          -  At least 1 week since prior chemotherapy

          -  No concurrent chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  See Disease Characteristics

          -  No prior external beam radiotherapy to the head or neck, including stereotactic
             radiotherapy

          -  Concurrent thoracic radiotherapy allowed

        Surgery

          -  Not specified

        Other

          -  No concurrent antitumor agents