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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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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

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. feasibility and tolerance

Secondary Outcome Measures :

1. efficacy

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00129051 History of Changes
Other Study ID Numbers:	NA-15-0005
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