combination chemotherapy and radiation therapy in treating patients with stage ii or stage iii non-small cell lung cancer that cannot be removed by surgery

Conditions: Lung Cancer

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.

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.

Eligibility 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

Keywords: stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer