Study of Tomotherapy in Patients With Benign Brain Tumour

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00128986
First received: August 9, 2005
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Brain Neoplasms
Procedure: Tomotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Tomotherapy in Patients With Benign Brain Tumour

Resource links provided by NLM:


Further study details as provided by AHS Cancer Control Alberta:

Primary Outcome Measures:
  • safety and adverse effects [ Time Frame: Trial Completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • efficacy and survival [ Time Frame: Trial completion ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: May 2005
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Tomotherapy
    3T MRS scans (3T magnetic resonance spectroscopy)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128986

Locations
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
Principal Investigator: Wilson Roa, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00128986     History of Changes
Other Study ID Numbers: CNS-09-0029 / ethics 21879
Study First Received: August 9, 2005
Last Updated: March 4, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
radiotherapy
brain

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014