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Helical Tomotherapy as a Radiotherapy Technique for Treating Pelvic and Abdominal Metastases

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00129051
First Posted: August 11, 2005
Last Update Posted: February 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AHS Cancer Control Alberta
  Purpose
Radiation treatment is often used to treat cancer that has spread to the abdomen. It can be very effective at relieving symptoms such as pain, but the radiotherapy itself can cause side-effects such as cramping and diarrhea. This study will investigate whether it is possible to reduce the unwanted side-effects of radiotherapy with a new technology called "helical tomotherapy". Tomotherapy is a new way to deliver radiation in a much more accurate fashion than is currently done, and with less radiation being delivered to normal tissues around the tumor. This study will involve the treatment of 20 patients, who have a spread of their cancer within the abdomen and pelvis, using helical tomotherapy. The dose and energy of radiation will be the same as is currently used - only the delivery system is different. The purpose is to assure that tomotherapy is a safe way to deliver radiation treatment and to investigate whether it will reduce the toxicity of radiation treatment in these patients. Patients will be treated in groups of three until all 20 have been treated. The toxicity of treatment will be measured with a questionnaire for each one. If any unexpected severe treatment complications occur, further accrual will stop.

Condition Intervention Phase
Neoplasm Metastasis Carcinoma Procedure: Tomotherapy Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Helical Tomotherapy as a Radiotherapy Technique for Treating Pelvic and Abdominal Metastases

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • feasibility and tolerance

Secondary Outcome Measures:
  • efficacy

Estimated Enrollment: 20
Study Start Date: August 2001
Estimated Study Completion Date: November 2005
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Intra-abdominal metastatic cancer

Exclusion Criteria:

  • Prior abdominal radiotherapy
  • Patient refusal
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129051


Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Robert Pearcey, MD AHS Cancer Control Alberta
  More Information

ClinicalTrials.gov Identifier: NCT00129051     History of Changes
Other Study ID Numbers: NA-15-0005
First Submitted: August 9, 2005
First Posted: August 11, 2005
Last Update Posted: February 9, 2010
Last Verified: November 2005

Keywords provided by AHS Cancer Control Alberta:
tomotherapy
metastatic carcinoma

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes