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RTOG 0538   |   CC707
Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide

Disease(s)
Lung
Hospital(s)
Fairview
Hillcrest
Independence
Main Campus
North Coast Cancer
Strongsville
Wooster
Phase(s)
Phase 3
Stage(s)
Type(s)
Ancillary
Drug(s)
Cisplatin
Etoposide

Contact Information
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Description
  1. 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.

Inclusion Criteria
  1. Histologically or cytologically documented small cell lung cancer
  2. 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.
  3. 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.
  4. No prior radiotherapy or chemotherapy for SCLC.
  5. No prior mediastinal or thoracic radiotherapy
  6. Patients with complete surgical resection of disease are not eligible.
  7. Age ≥ 18 years of age.
  8. ECOG Performance Status 0-2
  9. No patients that are known to be pregnant or nursing
  10. 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
Exclusion Criteria Not Available

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