Tomotherapy Treatment for Mesothelioma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Alberta Health Services

ClinicalTrials.gov Identifier:

NCT00469196

First received: May 2, 2007

Last updated: April 5, 2012

Last verified: April 2012

History of Changes

Purpose

Mesothelioma is an incurable cancer involving the lining of the lung. Patients usually suffer progressive symptoms of shortness of breath and chest pain, until they ultimately succumb to the disease. While a very small number of patients qualify for aggressive treatment with surgery, chemotherapy and radiation, and enjoy long-term survival, the vast majority of patients have incurable disease. The treatment options currently available, including chemotherapy and radiation treatment, are only modestly effective at alleviating symptoms and improving life expectancy. This trial explores the use of new radiation technology (tomotherapy), to treat mesothelioma more aggressively than has been possible before. Tomotherapy's ability to treat unusual shaped tumours, particularly when they are wrapped around sensitive normal tissues (the lung), enable higher doses of radiation to be used and this may improve its effectiveness. We will treat 17 patients with tomotherapy and assess the breathing, symptoms, and quality of life of the patients before and after treatment

Condition	Intervention	Phase
Mesothelioma	Procedure: Tomotherapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Tomotherapy Treatment for Mesothelioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Mesothelioma

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Primary Outcome Measures:

Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Disease-specific symptom control rate post-treatment, based on Palliation Index [7].

Secondary Outcome Measures:

Breathing Function [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Pulmonary function test results at 1, 3 and 6 months post treatment
Survival/Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
performance status at 1, 3 and 6 months post treatment; and overall survival

Estimated Enrollment:	17
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Intervention Details:

40 Gy in 15 fractions, at one fraction per day. Dose will be prescribed to the 95% isodose line.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

histologic mesothelioma
refused/ineligible for surgery or chemotherapy
life expectancy >3 months

Exclusion Criteria:

contraindications to thoracic radiotherapy
unable to lie flat for duration of radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469196

Locations

Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T5N 2R8

Sponsors and Collaborators

Alberta Health Services

Investigators

Principal Investigator:

Rufus Scrimger, MD

Alberta Health Services

More Information

No publications provided

Responsible Party:	Alberta Health Services
ClinicalTrials.gov Identifier:	NCT00469196 History of Changes
Other Study ID Numbers:	LU-11-0077 / 22933
Study First Received:	May 2, 2007
Last Updated:	April 5, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Alberta Health Services:

mesothelioma
tomotherapy

Additional relevant MeSH terms:

Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial

ClinicalTrials.gov processed this record on May 16, 2013

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