Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Dose-limiting toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- Local regional tumor control [ Time Frame: 6 month ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Radiation: hypofractionated radiation therapy
hypofractionated radiation therapy
Other Name: IGRT
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986297
|United States, California|
|Stanford, California, United States, 94305|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Robert D. Timmerman, MD||Simmons Cancer Center|