Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors
Recruitment status was Recruiting
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Abdominal compression methods that hold the body and the tumor from moving during treatment may permit radiation therapy to kill more tumor cells. This study is looking at the comfort level of two abdominal compression methods in patients with lung tumors undergoing stereotactic body radiation therapy.
PURPOSE: This phase I trial is studying the comfort level of two abdominal compression methods used to hold patients still while undergoing stereotactic body radiation therapy for lung tumors.
Other: questionnaire administration
Procedure: computed tomography
Radiation: radiation therapy treatment planning/simulation
|Study Design:||Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Study of Automated Abdominal Compression Device and Screw Based Abdominal Compression Devices During Stereotactic Body Radiation Therapy of Lung Tumors|
- Patient comfort score [ Designated as safety issue: No ]
- Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
- To evaluate comfort associated with the existing screw-based abdominal compression device and the new automated abdominal compression device in patients with lung tumors undergoing stereotactic body radiotherapy.
- To evaluate tumor motion in patients using these devices.
OUTLINE: This is a multicenter study.
Patients undergo fluoroscopic assessment of tumor motion with a screw-based abdominal compression device. Patients then undergo non-contrast 4D-CT imaging with the screw-based abdominal compression device followed by contrast 4D-CT imaging with an automated abdominal compression device.
Immediately after stereotactic body radiotherapy simulation, patients complete a questionnaire to assess the overall level of comfort of each abdominal-compression device.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866086
|United States, Texas|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Clinical Trials Office - Simmons Comprehensive Cancer Center a 866-460-4673; 214-648-7097|
|Principal Investigator:||Robert D. Timmerman, MD||Simmons Cancer Center|