radiation therapy in treating patients with stage i non-small cell lung cancer and lung dysfunction

Conditions: Lung Cancer

Summary: rationale: specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. purpose: phase i trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage i non-small cell lung cancer and lung dysfunction.

objectives: * determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage i non-small cell lung cancer with pulmonary dysfunction. * determine the short-term and long-term toxicity of this regimen in these patients. * determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen. * determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients. outline: this is a dose-escalation, multicenter study. patients receive accelerated 3-dimensional (3-d) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. cohorts of 8 patients receive escalating fractions of accelerated 3-d conformal radiotherapy until the maximum tolerated course is determined. the maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed stage i (t1-2, n0) non-small cell lung cancer (nsclc) * squamous cell carcinoma * basaloid carcinoma * adenocarcinoma * bronchoalveolar carcinoma * adenosquamous carcinoma * large cell carcinoma * large cell neuroendocrine carcinoma * giant cell carcinoma * sarcomatoid carcinoma * non-small cell carcinoma not otherwise specified * tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest ct scan (lung windows) * no metastatic disease or hilar or mediastinal lymphadenopathy * must have mediastinoscopy\* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest ct scan * no positive lymph nodes on mediastinoscopy\* note: \*patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose f 18 uptake in the mediastinum and hilum * poor surgical risk, as defined by 1 of the following: * high risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy * pulmonary dysfunction indicated by one or more of the following: * fev_1 less than 40% of predicted * dlco less than 50% of predicted * oxygen dependent * chronic paco_2 greater than 45 mm hg * vo_2 less than 15 ml/kg/min patient characteristics: age: * 18 and over performance status: * 0-2 other: * not pregnant or nursing * fertile patients must use effective contraception * no weight loss of more than 10% within the past 6 months * no other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer chemotherapy: * no prior chemotherapy for nsclc radiotherapy: * no prior chest radiotherapy

Keywords: stage i non-small cell lung cancer squamous cell lung cancer large cell lung cancer adenocarcinoma of the lung adenosquamous cell lung cancer bronchoalveolar cell lung cancer