high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage i, stage ii, or stage iiia non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: using computer systems that create a 3-dimensional picture of the tumor to plan treatment may enable doctors to provide more effective radiation therapy that will cause less damage to normal tissue. purpose: this phase i trial is studying the side effects and best dose of high-dose 3-dimensional conformal radiation therapy in treating patients with inoperable stage i, stage ii, or stage iiia non-small cell lung cancer.

objectives: * determine the optimal dose of high-dose 3-dimensional conformal radiotherapy in patients with inoperable stage i, ii, or iiia non-small cell lung cancer who are treated according to the total lung volume irradiated. * determine the feasibility of this regimen, in terms of local control rates and incidence of distant metastases, in these patients. outline: this is an open-label, nonrandomized, dose-escalation, multicenter study. patients are assigned to 1 of 3 strata according to the total lung volume irradiated (less than 25% vs 25-37% vs over 37%). * stratum i: patients undergo high-dose 3-dimensional (3-d) conformal radiotherapy 5 days a week for 6 weeks. * stratum ii: patients undergo high-dose 3-d conformal radiotherapy 5 days a week for 5.5-7 weeks. * stratum iii: patients undergo high-dose 3-d conformal radiotherapy 5 days a week for 5.5-6.5 weeks. cohorts of 6-15 patients in each stratum receive escalating dose intensities of high-dose 3-d conformal radiotherapy (either by increasing the total dose or by shortening treatment time) until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 2 of 6, 2 of 15, or 3 of 30 patients experience dose-limiting toxicity. patients are followed at 1 month, at least every 2 months for 1 year, every 3 months for 1 year, and then every 6 months thereafter. projected accrual: a total of 54-135 patients (18-45 per stratum) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed non-small cell lung cancer * medically inoperable stage i or ii disease * stage iii disease eligible provided the following are true: * no supraclavicular node involvement * no peripherally located lower lobe tumor and contralateral upper mediastinal node involvement * no distant metastasis * no malignant pleural or pericardial effusion patient characteristics: age * not specified performance status * who 0-2 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified cardiovascular * no prior myocardial infarction * no prior complete bundle branch block * no other prior cardiovascular disease resulting in new york heart association class iii or iv heart disease * no clinically significant cardiac arrhythmias * no congestive heart failure pulmonary * fev_1 at least 1.2 l or * dlco at least 60% other * no other prior or concurrent malignancy except cured basal cell skin cancer or carcinoma in situ of the cervix * no intractable or uncontrolled infection * no psychological, familial, social, or geographical condition that would preclude study compliance and follow-up * able to tolerate a course of radiotherapy prior concurrent therapy: biologic therapy * not specified chemotherapy * at least 3 weeks since prior chemotherapy * no prior anthracyclines * no concurrent chemotherapy endocrine therapy * not specified radiotherapy * no prior radiotherapy to the chest area surgery * no prior therapeutic surgery to the chest area other * no other prior therapy to the chest area

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