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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Patient comfort score

Safety Issue:

No

Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Simmons Cancer Center

Authority:

Unspecified

Study ID:

CDR0000634652

NCT ID:

NCT00866086

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms

Name

Location
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390