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Study of Tomotherapy in Patients With Benign Brain Tumour

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00128986
First Posted: August 11, 2005
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AHS Cancer Control Alberta
  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
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • efficacy and survival [ Time Frame: Trial completion ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): 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

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00128986     History of Changes
Other Study ID Numbers: CNS-09-0029 / ethics 21879
First Submitted: August 9, 2005
First Posted: August 11, 2005
Last Update Posted: April 6, 2016
Last Verified: March 2016

Keywords provided by AHS Cancer Control Alberta:
radiotherapy
brain

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