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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

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
questionnaire administration
computed tomography
radiation therapy treatment planning/simulation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Outcomes

Primary Outcome Measures

Patient comfort score

Secondary Outcome Measures

Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging

Full Information

First Posted
March 19, 2009
Last Updated
August 19, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00866086
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
February 2009 (Actual)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
computed tomography
Intervention Type
Radiation
Intervention Name(s)
radiation therapy treatment planning/simulation
Primary Outcome Measure Information:
Title
Patient comfort score
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Tumor motion as measured by screw-based and automated abdominal compression devices and 4D-CT imaging
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Timmerman, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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