Frameless Stereotactic Radiosurgery for Brain Metastases

NCT ID: NCT01476878

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-01-31

Brief Summary

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The investigators plan to study high dose, single treatment radiation, using a plastic mask instead of a head frame that pins into a patient's skull. The investigators need to (1) quantify set-up accuracy and patient motion during radiation treatment and (2) ensure that without the head frame the tumour control rate and risk of complications are similar to our previous experience using the head frame.

Detailed Description

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Conditions

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Brain Metastases

Keywords

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Radiosurgery Frameless radiosurgery Accuracy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Arm

Each study patient will receive high dose, single treatment radiation using a plastic mask instead of a head frame that pins into a patient's skull.

Group Type EXPERIMENTAL

Frameless Stereotactic Radiosurgery with radiation mask

Intervention Type DEVICE

Linac-based radiosurgery using a thermoplastic mask (single treatment)

Interventions

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Frameless Stereotactic Radiosurgery with radiation mask

Linac-based radiosurgery using a thermoplastic mask (single treatment)

Intervention Type DEVICE

Other Intervention Names

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Frameless Stereotactic Radiosurgery using radiation mask

Eligibility Criteria

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Inclusion Criteria

* Patients with brain metastases from a biopsy-proven primary extra-cranial tumor site, excluding lymphoma, germ cell, and small cell lung carcinoma histologies.
* One to four metastases, and all lesions \< 3.5 cm in maximal diameter. Extracranial metastases is of minimal volume or stable with treatment. - Karnofsky performance status ≥ 70

Exclusion Criteria

* None of the lesions is abutting or within critical neurological structures: \*brainstem

* optic chiasm
* eye, and optic nerve.
* The clearance between metastatic lesions and all critical structures must be at least 2 mm.
* Patients must not have leptomeningeal disease.
* Contraindications to imaging or radiation (e.g. pregnancy, elevated serum creatinine, allergy to contrast agents, severe claustrophobia, metal particles in the eye).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tom Baker Cancer Centre

OTHER

Sponsor Role collaborator

Alberta Health services

OTHER

Sponsor Role lead

Responsible Party

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Tom Baker Cancer Centre

Principal Investigators

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Jon-Paul Voroney, MD

Role: PRINCIPAL_INVESTIGATOR

Tom Baker Cancer Centre

Locations

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Tom Baker Cancer Centre

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jon-Paul Voroney, Phd. M.D.

Role: CONTACT

Phone: 403-521-3164

Email: [email protected]

Other Identifiers

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FRAMELESS SRS

Identifier Type: -

Identifier Source: org_study_id