Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Status: Recruiting
Phase: Phase 3
Diagnosis: Lung Cancer
NCT ID: NCT00632853 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-134

 

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. PURPOSE: This randomized phase III trial is comparing two different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Dana Farber Cancer Institute at Milford, Dana Farber Cancer Institute at South Shore Hospital, Massachusetts General Hospital

Overall PI:
David Kozono, MD, PhD, Dana Farber Cancer Institute

Site-responsible Investigators:
Christine Olsen, MD, Dana Farber Cancer Institute at Milford

Contacts:
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer - Limited-stage disease - Disease restricted to one hemithorax with regional lymph node metastases, including ipsilateral hilar, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular lymph nodes - The following patients are not eligible: - Patients with disease involvement of the contralateral hilar or supraclavicular lymph nodes - Patients with pleural effusions that are visible on plain chest radiographs, whether cytologically positive or not - Patients with cytologically positive pleural or pericardial fluid, regardless of the appearance on plain x-ray - Measurable disease, defined as at least one unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Granulocytes ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Total bilirubin ≤ 1.5 times upper limit of normal (ULN) - AST ≤ 2.0 times ULN - Serum creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 70 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: - No prior chemotherapy or radiotherapy for small cell lung cancer (SCLC) - No prior mediastinal or thoracic radiotherapy - No prior complete surgical resection of SCLC - No concurrent treatment with hormones or other chemotherapeutic agents except for steroids given for adrenal failure; hormones administered for non-disease-related conditions (e.g., insulin for diabetes); and intermittent use of dexamethasone as an antiemetic
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