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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Determine the maximum dose of external beam irradiation
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.