Study of Tomotherapy in Patients With Benign Brain Tumour

Brain Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128986
• Other study ID #: CNS-09-0029 / ethics 21879
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2005
• Last updated: April 5, 2016
• Start date: May 2005
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and adverse effects		Trial Completion	Yes
Secondary	efficacy and survival		Trial completion	Yes