Lung Cancer
Conditions
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES: * Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT). * Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients. * Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines. * Determine the feasibility of patient-specific dose escalation using this regimen in these patients. * Determine the quality of life and symptom distress in these patients on this regimen. OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT). Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks. Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels. Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months. Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.
Interventions
DRUGcarboplatin
DRUGpaclitaxel
RADIATIONradiation therapy
Sponsors
Baptist Health South Florida
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Patients with unresected locally advanced non-small cell lung cancer * Stage II, IIIA, or IIIB * No evidence of hematogenous metastases * No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) * No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 2,000/mm3 * Platelet count at least 130,000/mm3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No active or symptomatic cardiac disease * No acute myocardial infarction within the past 6 months * No angina * No congestive heart failure * No uncontrolled arrhythmias * Cardiac ejection fraction greater than 50% Pulmonary: * FEV1 at least 1.25 L AND * DLCO at least 50% predicted Other: * Not pregnant * Fertile patients must use effective contraception * Weight loss no greater than 5% within 3 months of diagnosis * No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior thoracic or neck radiotherapy Surgery: * See Disease Characteristics
Countries
United States
Outcome results
None listed