Lung Cancer Clinical Trial
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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