Tomotherapy Treatment for Mesothelioma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AHS Cancer Control Alberta

ClinicalTrials.gov Identifier:

NCT00469196

First received: May 2, 2007

Last updated: April 5, 2016

Last verified: March 2016

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 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: Mesothelioma

Genetic and Rare Diseases Information Center resources: Malignant Mesothelioma

U.S. FDA Resources

Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	18
Study Start Date:	October 2006
Study Completion Date:	May 2015
Primary Completion Date:	May 2015 (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 (Adult, Senior)
Sexes Eligible for Study:	All
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

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, see Learn About Clinical Studies.

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

AHS Cancer Control Alberta

Investigators


Principal Investigator:	Rufus Scrimger, MD	AHS Cancer Control Alberta

More Information


Responsible Party:	AHS Cancer Control Alberta
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, 2016

Keywords provided by AHS Cancer Control Alberta:


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 25, 2017

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