Tomotherapy Treatment for Mesothelioma
1 other identifier
interventional
18
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 2, 2007
CompletedFirst Posted
Study publicly available on registry
May 4, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedApril 6, 2016
March 1, 2016
8.6 years
May 2, 2007
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
Disease-specific symptom control rate post-treatment, based on Palliation Index \[7\].
6 months
Secondary Outcomes (2)
Breathing Function
6 months
Survival/Response Rate
6 months
Interventions
40 Gy in 15 fractions, at one fraction per day. Dose will be prescribed to the 95% isodose line.
Eligibility Criteria
You may qualify if:
- histologic mesothelioma
- refused/ineligible for surgery or chemotherapy
- life expectancy \>3 months
You may not qualify if:
- contraindications to thoracic radiotherapy
- unable to lie flat for duration of radiation therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cross Cancer Institute
Edmonton, Alberta, T5N 2R8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rufus Scrimger, MD
AHS Cancer Control Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2007
First Posted
May 4, 2007
Study Start
October 1, 2006
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
April 6, 2016
Record last verified: 2016-03