combination chemotherapy followed by radiation therapy before surgery in treating patients with stage iiib nsclc

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 before surgery may shrink the tumor so that it can be removed during surgery. purpose: phase ii trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage iiib non-small cell lung cancer.

objectives: * determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage iiib non-small cell lung cancer. * determine the rate of event-free survival at 1 year in patients treated with this regimen. * determine the operability and complete resection rate in patients treated with this regimen. * determine the postoperative 30-day mortality in patients treated with this regimen. * determine the response rate, failure pattern, and overall survival in patients treated with this regimen. * determine the toxicity of this regimen in these patients. outline: this is a multicenter study. patients receive docetaxel iv over 1 hour and cisplatin iv over 1 hour on day 1. treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity. beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19. patients undergo surgery within 3-4 weeks after completion of radiotherapy. patients are followed at 1 month and then every 3 months thereafter. projected accrual: a total of 15-46 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed, operable stage iiib non-small cell lung cancer * t4 n0-3 m0 or t1-4 n3 m0 by bronchoscopy and mediastinoscopy (required for assessment of n3 disease) or ct scan or mri of the thorax * squamous cell * adenosquamous cell * large cell * poorly differentiated * no prior or concurrent metastatic disease by ct scan or mri of the brain, bone scan, and abdominal ultrasound or ct scan * no malignant pleural or pericardial effusion * no invasion of the aorta, esophagus, myocardium, or supraclavicular nodes patient characteristics: age: * 18 to 75 performance status: * who 0-1 life expectancy: * not specified hematopoietic: * wbc at least 4,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin normal * ast and/or alt no greater than 1.5 times upper limit of normal (uln) * alkaline phosphatase no greater than 2.5 times uln renal: * creatinine clearance at least 60 ml/min cardiovascular: * no unstable cardiac disease requiring treatment * no congestive heart failure * no angina pectoris (even if medically controlled) * no significant arrhythmia * no myocardial infarction within the past 3 months other: * not pregnant or nursing * fertile patients must use effective contraception * no definite contraindications for the use of corticosteroids as premedication * no preexisting grade 2 or greater peripheral neuropathy * no active uncontrolled infection * no uncontrolled diabetes mellitus * no other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix * no prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent * no other serious underlying medical condition that would preclude study participation * no socioeconomic or geographical circumstances that would preclude study compliance prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * no concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent) radiotherapy: * no prior radiotherapy to the chest surgery: * see disease characteristics other: * at least 30 days since prior treatment in a clinical trial * no prior cytostatic therapy * no other concurrent experimental drugs

Keywords: squamous cell lung cancer large cell lung cancer stage iiib non-small cell lung cancer adenosquamous cell lung cancer