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. The completion date has passed and the status has not been verified in more than two years.

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

History of Changes

Tracking Information

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

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

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: 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

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, Senior)

Accepts Healthy Volunteers

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

Plan to Share Data

Not Provided

IPD Description

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

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