Study of Tomotherapy in Patients With Benign Brain Tumour

April 5, 2016 updated by: AHS Cancer Control Alberta

A Phase I 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.

Study Overview

Status

Completed

Conditions

Brain Neoplasms

Intervention / Treatment

Procedure: Tomotherapy

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
safety and adverse effects Time Frame: Trial Completion	Trial Completion

Secondary Outcome Measures

Outcome Measure	Time Frame
efficacy and survival Time Frame: Trial completion	Trial completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHS Cancer Control Alberta

Investigators

Principal Investigator: Wilson Roa, MD, AHS Cancer Control Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 9, 2005

First Submitted That Met QC Criteria