Overview

This trial is active, not recruiting.

Condition brain neoplasms
Treatment tomotherapy
Phase phase 1
Sponsor AHS Cancer Control Alberta
Start date May 2005
End date July 2014
Trial size 49 participants
Trial identifier NCT00128986, CNS-09-0029 / ethics 21879

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
safety and adverse effects
time frame: Trial Completion

Secondary Outcomes

Measure
efficacy and survival
time frame: Trial completion

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Phase I Study of Tomotherapy in Patients With Benign Brain Tumour
Principal investigator Wilson Roa, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by AHS Cancer Control Alberta.