Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer
Trial status: Open for Enrollment
Why is this study being done?
- To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.
- To evaluate the rate of radiographic response to treatment.
- To estimate the rates of progression: local/regional/distant.
- To estimate the progression-free survival.
- To estimate the overall survival.
OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy.
Concurrent therapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4 to 5.5 weeks.
Consolidation therapy: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Who is eligible to participate?
- 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
- Pleural/pericardial effusion
- Inflammatory breast disease
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- 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