Tomotherapy Treatment for Mesothelioma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00469196
First received: May 2, 2007
Last updated: March 4, 2014
Last verified: March 2014
  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:


Further study details as provided by AHS Cancer Control Alberta:

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


Enrollment: 18
Study Start Date: October 2006
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (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
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
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

No publications provided

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: March 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
mesothelioma
tomotherapy

Additional relevant MeSH terms:
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 26, 2014