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Tomotherapy Treatment for Mesothelioma
This study has been completed.
Sponsor:
AHS Cancer Control Alberta
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
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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:
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:
-
Procedure: Tomotherapy
40 Gy in 15 fractions, at one fraction per day. Dose will be prescribed to the 95% isodose line.
Show Detailed Description
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00469196
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 July 19, 2017