Lung Cancer Clinical Trial
Official title:
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to
the tumor may kill more tumor cells and cause less damage to normal tissue.
PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy
in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
OBJECTIVES:
- Determine the maximum tolerated course of accelerated 3-dimensional conformal
radiotherapy in patients with stage I non-small cell lung cancer with pulmonary
dysfunction.
- Determine the short-term and long-term toxicity of this regimen in these patients.
- Determine local tumor control, failure-free survival, and overall survival in patients
treated with this regimen.
- Determine the effect of radiotherapy dose volume relationships and pre-treatment
pulmonary function studies on the incidence of pulmonary toxicity in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week
for 3.5-6 weeks.
Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy
until the maximum tolerated course is determined. The maximum tolerated course is defined as
the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity
and no more than 1 patient develops at least grade 4 dose-limiting toxicity.
Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then
every 6 months for 3 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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