NCT01476878

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

November 22, 2011

Status Verified

August 1, 2011

Enrollment Period

2 years

First QC Date

July 9, 2010

Last Update Submit

November 18, 2011

Conditions

Brain Metastases

Keywords

RadiosurgeryFrameless radiosurgeryAccuracy

Outcome Measures

Primary Outcomes (1)

  • Quantification of patient movement occurring during treatment.

    overall

Secondary Outcomes (2)

  • Local tumour control

    overall

  • risk of complication (radionecrosis)

    overall

Study Arms (1)

Open Arm

EXPERIMENTAL

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.

Device: Frameless Stereotactic Radiosurgery with radiation mask

Interventions

Frameless Stereotactic Radiosurgery with radiation maskDEVICE

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

Also known as: Frameless Stereotactic Radiosurgery using radiation mask
Open Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jon-Paul Voroney, MD

    Tom Baker Cancer Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jon-Paul Voroney, Phd. M.D.

CONTACT

403-521-3164Jon-Paul.Voroney@albertahealthservices.ca

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2010

First Posted

November 22, 2011

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

November 22, 2011

Record last verified: 2011-08

Locations

CA(1)