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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00866086
First received: March 19, 2009
Last updated: April 18, 2009
Last verified: March 2009

March 19, 2009
April 18, 2009
February 2009
February 2010   (final data collection date for primary outcome measure)
Patient comfort score [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00866086 on ClinicalTrials.gov Archive Site
Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors
Study of Automated Abdominal Compression Device and Screw Based Abdominal Compression Devices During Stereotactic Body Radiation Therapy of Lung Tumors

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.

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.

Interventional
Phase 1
Masking: Open Label
Primary Purpose: Diagnostic
Lung Cancer
  • Other: questionnaire administration
  • Procedure: computed tomography
  • Radiation: radiation therapy treatment planning/simulation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
Not Provided
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00866086
CDR0000634652, SCCC-122008-012
Not Provided
Robert Dale Timmerman, Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Simmons Cancer Center
Not Provided
Principal Investigator: Robert D. Timmerman, MD Simmons Cancer Center
National Cancer Institute (NCI)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP