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

Lung Cancer Clinical Trial

Official title:

Study of Automated Abdominal Compression Device and Screw Based Abdominal Compression Devices During Stereotactic Body Radiation Therapy of Lung Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00866086
• Other study ID #: SCCC-122008-012
• Secondary ID: CDR0000634652
• Status: Terminated
• Phase: Phase 1
• Start date: February 2009
• Est. completion date: September 2009

Study information

• Verified date: March 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• questionnaire administration

Procedure:
• computed tomography

Radiation:
• radiation therapy treatment planning/simulation

Locations

Country	Name	City	State
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort score		10 years
Secondary	Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging		10 years