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

IRB RTOG 0538

CC CC707

Hospital Fairview, Hillcrest, Independence, Main Campus, Mansfield, North Coast Cancer, Strongsville, Wooster

Phase Phase 3

Disease Lung

Drug Cisplatin, Etoposide

Description

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

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. Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide. If a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests outlined in Section 7.0 prior to starting their first cycle of chemotherapy. Additionally, these patients also must have met all of the eligibility criteria in Section 4.0 prior to receiving the first cycle of chemotherapy. Registration to CALGB 30610 must take place within 7-21 days after the start of the non-protocol therapy. Failing to do all of the above will make the patient NOT eligible for CALGB 30610.
  5. No prior radiotherapy or chemotherapy (except for the chemotherapy described in the bullet above) for SCLC.
  6. No prior mediastinal or thoracic radiotherapy
  7. Patients with complete surgical resection of disease are not eligible.
  8. Age ≥ 18 years of age.
  9. ECOG Performance Status 0-2
  10. No patients that are known to be pregnant or nursing
  11. 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

Exclusion Criteria Not Available