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
Tracking Information | |||||
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First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | April 18, 2009 | ||||
Start Date ICMJE | February 2009 | ||||
Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Patient comfort score [ Designated as safety issue: No ] | ||||
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 |
Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Masking: Open Label Primary Purpose: Diagnostic |
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Condition ICMJE | Lung Cancer | ||||
Intervention ICMJE |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 10 | ||||
Completion Date | |||||
Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | |||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866086 | ||||
Other Study ID Numbers ICMJE | CDR0000634652, SCCC-122008-012 | ||||
Has Data Monitoring Committee | |||||
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 | |||||
Investigators ICMJE |
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Information Provided By | 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 |