Status:
TERMINATED
Perfexion Brain Metastasis
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Brain metastases occur in 20% to 40% of all patients with cancer , with an incidence 10 times higher than that of primary malignant brain tumors. Patients with brain metastases have a poor prognosis w...
Detailed Description
With increasing volume of tumor, the dose of radiosurgery that can be safely delivered to recurrent oligo-metastases in the brain must be reduced. However, reducing the dose of radiosurgery also compr...
Eligibility Criteria
Inclusion
- 1-5 recurrent brain metastases after WBRT, and
- At least 1 lesions \>2cm in maximum diameter
- ECOG 0-2
- Life expectancy \>3months
- Age ≥ 18 years old
Exclusion
- Edentulous patients
- Prior surgery or injury to hard palate
- Severe claustrophobia
- Contraindication to MRI
- Contraindication to IV contrast (Gadolinium) administration
- Other medical conditions that would preclude study investigations
- Prior radiosurgery to recurrent lesions
- Radiation cannot be delivered at the assigned dose level in a manner that respects OAR constraints (3.2.2.4.2.3.4) (e.g. lesions within brainstem or abutting optic structures)
- Any lesion \>5cm in diameter, or total volume of tumor \> 60cc
- Pregnant Women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00805103
Start Date
December 1 2008
End Date
March 1 2016
Last Update
December 29 2016
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5G 2M9