NCT01970644

Brief Summary

Cancer which spreads to the brain (brain metastases) is a common and significant problem. Historically, whole-brain radiotherapy has been used to treat these patients but has a negative effect on cognition. Radiosurgery is an alternative treatment with potential for fewer cognitive side effects. The impact of radiosurgery alone on the cognitive function of patients with multiple brain metastases is not well studied. We propose a pilot study at the Winnipeg Centre for Gamma Knife Surgery to examine this issue.

Trial Health

57
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Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 23, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 28, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 30, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

October 23, 2013

Last Update Submit

May 27, 2016

Conditions

Neoplasm Metastases

Keywords

Neoplasm metastasisBrain neoplasmsRadiosurgeryCognition disordersCranial irradiation

Outcome Measures

Primary Outcomes (1)

  • Hopkins Verbal Learning Test - Revised (HVLT-R)

    4 months after radiosurgery

Secondary Outcomes (3)

  • Neurocognitive battery

    4 months after radiosurgery

  • Quality of Life

    4 months after radiosurgery

  • Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    4 months after radiosurgery

Other Outcomes (3)

  • Time to in-field and distant radiographic progression

    1 year

  • Duration of functional independence (Barthel ADL index)

    1 year

  • Neurologic death rate

    1 year

Study Arms (1)

Brain metastases (>= 4)

Patients with pathologically proven solid tumour malignancy who have \>=4 brain metastases will be treated with gamma knife radiosurgery.

Radiation: Gamma knife radiosurgery

Interventions

Gamma knife radiosurgeryRADIATION

Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.

Brain metastases (>= 4)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple (\>= 4) brain metastases undergoing radiosurgery at the Winnipeg Centre for Gamma Knife Surgery.

You may qualify if:

  • Pathologically proven solid tumour malignancy
  • Age \>= 18 years
  • Karnofsky performance status \>= 70
  • \>= 4 brain metastases, all eligible to be treated with radiosurgery
  • All brain metastases \<= 4.0 cm in any diameter
  • Pre-treatment contrast enhanced MRI brain \<= 42 days prior to enrollment
  • Patient able to provide his/her own written informed consent

You may not qualify if:

  • Prior radiosurgery, whole brain radiotherapy, or cranial radiotherapy
  • Previous surgical resection of brain metastasis (biopsy is allowed)
  • Prior chemotherapy ≤ 7 days prior to enrollment
  • Planned chemotherapy during radiosurgery
  • Leukemia, lymphoma, germ-cell tumour, small-cell lung cancer diagnosis
  • Brainstem metastasis
  • Leptomeningeal metastases
  • Contraindication to MR imaging with contrast
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre / CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

MeSH Terms

Conditions

Neoplasm MetastasisBrain NeoplasmsCognition Disorders

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Harvey Quon, MD

    CancerCare Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 28, 2013

Study Start

April 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 30, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)