Phase 1 Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status

University of Texas Southwestern Medical Center2 sites in 1 country60 target enrollmentOctober 2009

ConditionsLung Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: University of Texas Southwestern Medical Center
Enrollment: 60
Locations: 2
Primary Endpoint: Dose-limiting toxicity
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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: This phase I trial is studying the side effects and best dose of specialized radiation therapy in treating patients with stage II, stage III, stage IV, or recurrent non-small cell lung cancer and poor performance status.

Detailed Description

OBJECTIVES: Primary * To escalate the dose of accelerated hypofractionated image-guided conformal radiotherapy to a potent tumoricidal dose without exceeding the maximum-tolerated dose in patients with recurrent or stage II-IV non-small cell lung cancer and poor performance status. Secondary * To evaluate local regional tumor control and overall survival of patients treated with this regimen. OUTLINE: Patients undergo accelerated hypofractionated image-guided conformal radiotherapy once daily, 5 days a week, for 3 weeks (15 fractions). Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up periodically for up to 5 years.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

October 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group