combination chemotherapy plus radiation therapy followed by surgery in treating patients with stage iiib non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining chemotherapy with radiation therapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining chemotherapy and radiation therapy before surgery in treating patients who have stage iiib non-small cell lung cancer.

objectives: * determine the incidence of radically resected disease in patients with stage iiib non-small cell lung cancer treated with induction cisplatin, etoposide, and radiotherapy followed by surgical resection. * determine the toxicity (morbidity and mortality) of this regimen in these patients. * determine the clinical response rate and pathological response rate in patients treated with this regimen. outline: this is a multicenter study. patients receive induction chemotherapy comprising cisplatin iv on day 1 and etoposide iv on days 1-3. chemotherapy repeats every 3 weeks for 3 courses. beginning on day 2 of the second course of chemotherapy, patients undergo induction radiotherapy once daily 5 days a week for 5-7 weeks. chemoradiotherapy continues in the absence of disease progression or unacceptable toxicity. at 3-6 weeks after completion of the last dose of induction radiotherapy, patients undergo lobectomy or pneumonectomy. patients are followed at 30 days and 4 months, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 27-62 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed primary stage iiib non-small cell lung cancer (nsclc) * t4, any n, m0 or any t, n3, m0 * no n3 disease due to scalene or supraclavicular lymph node involvement * no primary tumors located in the lower lobe combined with contralateral upper higher mediastinal lymph node involvement * no mixed tumor types with small cell lung cancer * at least 1 unidimensionally measurable target lesion * at least 20 mm by conventional techniques or * at least 10 mm by spiral ct scan * no pre-existing pleural or pericardial effusion * no cns involvement by ct scan or mri patient characteristics: age: * 18 to 75 performance status: * who 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 2,000/mm\^3 * platelet count at least 100,000/mm \^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast/alt no greater than 1.5 times uln * alkaline phosphatase no greater than 2.5 times uln renal: * creatinine no greater than 1.25 times uln * creatinine clearance at least 60 ml/min cardiovascular: * no clinical evidence of superior vena cava syndrome pulmonary: * postoperative fev1 and kco greater than 40% predicted * vo2 max greater than 15 ml/min/kg (if postoperative kco no greater than 40% predicted) other: * no other primary malignancy except carcinoma in situ of the cervix, adequately treated basal cell skin cancer, or other malignancy treated more than 5 years ago without recurrence (excluding melanoma, breast cancer, or hypernephroma) * no active uncontrolled infection requiring iv antibiotics * no pre-existing sensory neurotoxicity grade 2 or greater * no psychological, familial, sociological, or geographical condition that would preclude study compliance * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no prior immunotherapy for nsclc * no concurrent immunotherapy during induction chemoradiotherapy * concurrent colony stimulating factors allowed chemotherapy: * no prior chemotherapy for nsclc endocrine therapy: * no concurrent anticancer hormonal agents (except corticosteroids for antiemetic prophylaxis) during induction chemoradiotherapy radiotherapy: * no prior radiotherapy for nsclc surgery: * no prior surgery for nsclc other: * no other concurrent anticancer drugs during induction chemoradiotherapy

Keywords: stage iiib non-small cell lung cancer