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Study of Tomotherapy in Patients With Benign Brain Tumour

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ClinicalTrials.gov Identifier: NCT00128986
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

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.

Condition or disease Intervention/treatment Phase
Brain Neoplasms Procedure: Tomotherapy Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
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
Study Start Date : May 2005
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
U.S. FDA Resources


Intervention Details:
    Procedure: Tomotherapy
    3T MRS scans (3T magnetic resonance spectroscopy)


Primary Outcome Measures :
  1. safety and adverse effects [ Time Frame: Trial Completion ]

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


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

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

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00128986     History of Changes
Other Study ID Numbers: CNS-09-0029 / ethics 21879
First Posted: August 11, 2005    Key Record Dates
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