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

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. Identifier: NCT00129051
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : February 9, 2010
Information provided by:
AHS Cancer Control Alberta

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasm Metastasis Carcinoma Procedure: Tomotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
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
Study Start Date : August 2001
Study Completion Date : November 2005

Primary Outcome Measures :
  1. feasibility and tolerance

Secondary Outcome Measures :
  1. efficacy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Intra-abdominal metastatic cancer

Exclusion Criteria:

  • Prior abdominal radiotherapy
  • Patient refusal

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 identifier (NCT number): NCT00129051

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

Layout table for additonal information Identifier: NCT00129051    
Other Study ID Numbers: NA-15-0005
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: November 2005
Keywords provided by AHS Cancer Control Alberta:
metastatic carcinoma
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes