Clinical trial NCT00866086: Comfort Level of Two Abdominal Compression Methods Used to Hold Patients Still While Undergoing Stereotactic Body Radiation Therapy for Lung Tumors
Official title: Study of Automated Abdominal Compression Device and Screw Based Abdominal Compression Devices During Stereotactic Body Radiation Therapy of Lung Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lung Cancer
Keywords: stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer
pulmonary carcinoid tumor
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient comfort score
timeFrame: 10 years
Secondary outcomes:
measure: Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging
timeFrame: 10 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Robert D. Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
References: