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OpenTrials
Completed

NCT Number: NCT00128986

Study of Tomotherapy in Patients With Benign Brain Tumour

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tomotherapy

Procedure

3T MRS scans (3T magnetic resonance spectroscopy)

Primary outcomes

  1. safety and adverse effects

    Time frame: Trial Completion

Secondary outcomes

  1. efficacy and survival

    Time frame: Trial completion

Sponsors and collaborators

Lead sponsor

AHS Cancer Control Alberta

Other

Registry information

Official study title

A Phase I Study of Tomotherapy in Patients With Benign Brain Tumour

Important dates

Study start
2005
Primary completion
2014
Study completion
2014
First posted
Aug 11, 2005
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.