Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Status: Recruiting
Phase:
Diagnosis: Radiation Oncology
NCT ID: NCT01486602 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-273

 

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving specialized radiation therapy together with chemotherapy may kill more tumor cells. PURPOSE: This phase I trial studies the side effects and the best dose of specialized radiation therapy giving together with chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Raymond Mak, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Brigham and Women's Hospital: Kristin Roper, 617-525-7387, kroper@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically or cytologically documented non-small cell lung cancer (NSCLC) - Stage: IIIA or IIIB NSCLC; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible - Tumor Site: Thoracic disease without supraclavicular or contralateral hilar involvement - Pleural Effusion: When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative - Exudative pleural effusions are excluded regardless of cytology - Patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible - Patients must have measurable disease - Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan - Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following: - Bone lesions - Leptomeningeal disease - Ascites - Pleural/pericardial effusion - Inflammatory breast disease - Lymphangitis cutis/pulmonis - Abdominal masses that are not confirmed and followed by imaging techniques - Cystic lesions PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - No patients that are known to be pregnant or nursing - Granulocytes ≥ 1,500/μl - Platelet count ≥ 100,000/μl - Bilirubin ≤1.5 times upper limit of normal (ULN) - AST (SGOT) ≤ 2.0 times ULN - Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 70 mL/min - FEV-1 ≥ 1.2 L/sec or 50% predicted PRIOR CONCURRENT THERAPY: - No prior radiotherapy or chemotherapy for non-small cell lung cancer (NSCLC) - No prior mediastinal or thoracic radiotherapy - Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible
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