Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors

Tracking Information
First Submitted Date ICMJE	March 19, 2009
First Posted Date ICMJE	March 20, 2009
Last Update Posted Date	April 21, 2009
Study Start Date ICMJE	February 2009
Estimated Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 19, 2009)	Patient comfort score
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00866086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 19, 2009)	Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors
Official Title ICMJE	Study of Automated Abdominal Compression Device and Screw Based Abdominal Compression Devices During Stereotactic Body Radiation Therapy of Lung Tumors
Brief Summary	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.
Detailed Description	OBJECTIVES: Primary; 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. Secondary; 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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Lung Cancer
Intervention ICMJE	Other: questionnaire administration; Procedure: computed tomography; Radiation: radiation therapy treatment planning/simulation
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: March 19, 2009)	10
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: All lung patients from the University of Texas Southwestern Medical Center, Parkland Health and Hospital System, and Richardson Regional Cancer Center scheduled to receive stereotactic body radiotherapy simulation; Must have initial pre-compression lung tumor motions with respiration > 1 cm PATIENT CHARACTERISTICS: Negative pregnancy test PRIOR CONCURRENT THERAPY: Concurrent participation in other protocols allowed
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00866086
Other Study ID Numbers ICMJE	CDR0000634652; SCCC-122008-012
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Robert Dale Timmerman, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Study Sponsor ICMJE	Simmons Cancer Center
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
PRS Account	National Cancer Institute (NCI)
Verification Date	March 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP