Study of Tomotherapy in Patients With Benign Brain Tumour
Primary Purpose
Brain Neoplasms
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Tomotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms focused on measuring radiotherapy, brain
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed newly diagnosed base of skull benign tumour Karnofsky Performance Status (KPS) equal to or greater than 70 Exclusion Criteria: Brain metastases or recurrent tumour Prior radiotherapy (RT) to head or neck No prior chemotherapy or radiosensitizer
Sites / Locations
- Cross Cancer Institute
Outcomes
Primary Outcome Measures
safety and adverse effects
Secondary Outcome Measures
efficacy and survival
Full Information
NCT ID
NCT00128986
First Posted
August 9, 2005
Last Updated
April 5, 2016
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT00128986
Brief Title
Study of Tomotherapy in Patients With Benign Brain Tumour
Official Title
A Phase I Study of Tomotherapy in Patients With Benign Brain Tumour
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Although malignant brain tumors are the most common type of primary brain tumor, there are a number of other benign brain tumors that exist. Many difficulties exist with treating these tumors that have led to controversies in the best treatment. A common issue among these brain tumors is the risk of long term side effects from treatment. What limits the use of curative radiation therapy is the ability to deliver a maximal dose to the tumor while minimizing the amount of radiation to the normal structures in the brain. A new method of delivering radiation, called tomotherapy, has been acquired at the Cross Cancer Institute (CCI) and will be used in this study. It has the ability to deliver a high dose of radiation to the tumor while minimizing the amount of radiation to normal brain structures. This study will use this method of radiation therapy to deliver radiation and see if the long term side effects from radiation therapy can be reduced.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms
Keywords
radiotherapy, brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Tomotherapy
Intervention Description
3T MRS scans (3T magnetic resonance spectroscopy)
Primary Outcome Measure Information:
Title
safety and adverse effects
Time Frame
Trial Completion
Secondary Outcome Measure Information:
Title
efficacy and survival
Time Frame
Trial completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically confirmed newly diagnosed base of skull benign tumour
Karnofsky Performance Status (KPS) equal to or greater than 70
Exclusion Criteria:
Brain metastases or recurrent tumour
Prior radiotherapy (RT) to head or neck
No prior chemotherapy or radiosensitizer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilson Roa, MD
Organizational Affiliation
AHS Cancer Control Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Tomotherapy in Patients With Benign Brain Tumour
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