Specialized Radiation Therapy in Treating Patients With Stage II, Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer and Poor Performance Status
|ClinicalTrials.gov Identifier: NCT00986297|
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : May 20, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: hypofractionated radiation therapy||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||October 2012|
Radiation: hypofractionated radiation therapy
hypofractionated radiation therapy
Other Name: IGRT
- Dose-limiting toxicity [ Time Frame: 90 days ]
- Local regional tumor control [ Time Frame: 6 month ]
- Overall survival [ Time Frame: 2 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|