Radiation Therapy Using 3-Dimensional Treatment Planning in Patients With Non-small Cell Lung Cancer
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A PHASE I TRIAL OF DOSE ESCALATION OF EXTERNAL BEAM RADIATION THERAPY USING CONFORMAL 3-DIMENSIONAL TREATMENT PLANNING FOR NON-SMALL CELL LUNG CANCER|
|Study Start Date:||October 1991|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
- 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.
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Kenneth Rosenzweig, MD||Memorial Sloan-Kettering Cancer Center|