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Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide
|North Coast Cancer
- To determine whether administering high dose thoracic radiotherapy, 70 Gy (2 Gy once-daily over 7 weeks) or 61.2 Gy (1.8 Gy once-daily for 16 days followed by 1.8 Gy twice daily for 9 days), will improve median and 2 year survival compared with 45 Gy (1.5 Gy twice daily over 3 weeks) in patients with limited stage small cell lung cancer.
- Histologically or cytologically documented small cell lung cancer
- Limited stage disease patients, with disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes.
- Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes are not eligible
- Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not, are not eligible unless they have negative thoracentesis.
- Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray, are not eligible.
- Patients must have measurable disease, which includes lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2cm with conventional techniques or as ≥ 1 cm with spiral CT scan.
- No prior radiotherapy or chemotherapy for SCLC.
- No prior mediastinal or thoracic radiotherapy
- Patients with complete surgical resection of disease are not eligible.
- Age ≥ 18 years of age.
- ECOG Performance Status 0-2
- No patients that are known to be pregnant or nursing
- Required Initial Laboratory Values:
- Granulocytes: ≥ 1,500/µl
- Platelet Count: ≥ 100,000/µl
- Total Bilirubin: ≤ 1.5 x ULN
- AST (SGOT): ≤ 2.0 x ULN
- Serum Creatine OR: ≤ 1.5 x ULN
- Calculated Creatine Clearance: ≥ 70ml/min
Exclusion Criteria Not Available
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