NCT00057746
Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
PHASE2
COMPLETED
NCT00057746
INTERVENTIONAL
A Phase II Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer
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).
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
Lung Cancer
- TREATMENT
-
- Type: RADIATION
- Name: Prophylactic cranial irradiation, 2.5 Gy fx
- Description: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy
- Arm Group Labels: Arm I
-
- Type: RADIATION
- Name: Prophylactic cranial irradiation, 2.0 Gy fx
- Description: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy
- Arm Group Labels: Arm II
-
- Type: RADIATION
- Name: Prophylactic cranial irradiation, 1.5 Gy fx
- Description: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy
- Arm Group Labels: Arm III
- Radiation Therapy Oncology Group