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Tomotherapy Treatment for Mesothelioma

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ClinicalTrials.gov Identifier: NCT00469196
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Mesothelioma Procedure: Tomotherapy Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tomotherapy Treatment for Mesothelioma
Study Start Date : October 2006
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Procedure: Tomotherapy
    40 Gy in 15 fractions, at one fraction per day. Dose will be prescribed to the 95% isodose line.

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


Secondary Outcome Measures :
  1. Breathing Function [ Time Frame: 6 months ]
    Pulmonary function test results at 1, 3 and 6 months post treatment

  2. Survival/Response Rate [ Time Frame: 6 months ]
    performance status at 1, 3 and 6 months post treatment; and overall survival


Eligibility Criteria
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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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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 ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00469196     History of Changes
Other Study ID Numbers: LU-11-0077 / 22933
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: March 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