radiation therapy using 3-dimensional treatment planning in patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. computer systems that allow doctors to create a 3-dimensional picture of the tumor in order to plan treatment may result in more effective radiation therapy. purpose: phase i trial to study the effectiveness of high-dose radiation therapy planned using a 3-dimensional picture of the tumor in treating patients who have stage i, stage ii, or stage iii non-small cell lung cancer.

objectives: * determine the maximum dose of external beam irradiation deliverable using conformal 3-dimensional treatment planning in patients with non-small cell lung cancer. * determine the feasibility and efficacy of 3-dimensional treatment planning in delivering high doses of external beam radiotherapy to these patients. * determine whether computer-generated dose-volume histograms and normal tissue complication probability models can predict the degree of pulmonary toxicity resulting from external beam radiotherapy. * determine the relationship between dose of external beam radiotherapy and the degree of pulmonary function change. outline: this is a dose escalation study. patients undergo 3-dimensional conformal external beam radiotherapy 5 days a week for 8-10 weeks. cohorts of 10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which no more than 20% of patients experience dose-limiting toxicity. patients are followed at 1 month and then every 4 months thereafter. projected accrual: a total of 60-70 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed non-small cell lung cancer * clinical stage t1-4, n0-2, m0 * clinical stage t1-2, n0-1 must be medically inoperable * no distant metastases on history and physical exam, cbc, screening profile, ct or mri of brain, ct of chest and abdomen (including adrenals and liver), and bone scan * no pleural effusions * atelectasis not clearly distinguishable from tumor mass allowed provided all tumor and atelectasis together represent a volume that can be safely treated to the total dose delivered to gross disease * diffuse pulmonary infiltrates thought to represent benign disease allowed only if representative lesion samples are proven by biopsy or cytology not to contain cancer * no diffuse bronchoalveolar carcinoma patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other malignancy within the past 5 years except nonmelanomatous skin cancer or noninvasive cervical carcinoma * no other medical illness that cannot be adequately controlled with appropriate therapy or that is considered severe enough to preclude a radical treatment approach prior concurrent therapy: biologic therapy * no prior biologic therapy for lung cancer chemotherapy * no prior chemotherapy for lung cancer endocrine therapy * no prior endocrine therapy for lung cancer radiotherapy * no prior radiotherapy for lung cancer surgery * no prior surgery for lung cancer

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