Perfexion Brain Metastasis

Phase 1

Terminated

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 with a median survival of 1-2 months with corticosteroids and 5-7 months with whole brain radiotherapy (WBRT). Local control achieved with WBRT in patients with otherwise controlled systemic disease remains at issue. A single high dose of radiation delivered with high precision to the target lesion (Stereotactic radiosurgery (SRS)), is considered standard care in salvage of recurrent lesions after WBRT. SRS can destroy tumour with very little damage to surrounding tissue. Research suggests that delivering radiotherapy in a number of smaller doses is more beneficial than receiving all of the radiotherapy in a single dose. Brain metastases are well suited for SRS as they are often small, radiographically well-circumscribed, pseudospherical tumors that are noninfiltrative.

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 compromises local control. There is mounting evidence of a local control benefit to a hypofractionated approach in radiation delivery for brain metastases compared with single fraction radiosurgery. Here we propose a novel therapeutic strategy that builds on this concept whereby time between each delivered fraction will enable us to measure and adapt to response, with the objective of reducing irradiated volumes and improving outcomes. In general, the treatment of malignant tumors benefits from fractionation of the dose due to a number of radiobiological properties (redistribution, reoxygenation, repair) that distinguish, and select against, malignant lesions in the fractionation process. Hypofractionated stereotactic radiotherapy (HSRT) is a method of delivering a highly conformal dose distribution in a few treatment sessions using a relocatable stereotactic frame. HSRT may be an attractive alternative to SRS because it may 1) improve patient comfort by removing the invasive nature of SRS frames, 2) confer a radiobiologic advantage over single fraction treatment.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
(HFA-SRT) in Large-Volume Brain Metastases	Hypofractionated stereotactic radiotherapy	-

Primary Outcome Measures

Name	Time	Method
This study aims to determine what the maximum tolerated dose of hypofractionated adaptive stereotactic radiotherapy (HFA-SRT) for recurrent brain metastases is.	every 3 months for 3 years

Secondary Outcome Measures

Name	Time	Method
The secondary outcome will be to evaluate the overall survival and change in tumour response.	every 3 months for 3 years
Measure acute and late toxicities	every 3 months for 3 years

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial