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Hypofractionated Stereotactic Radiotherapy (HF-SRT) for Large-Volume Brain Metastases

Phase 1
18 Years
Open (Enrolling)
Brain Metastases

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Trial Information

Hypofractionated Stereotactic Radiotherapy (HF-SRT) for Large-Volume Brain Metastases

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.

Inclusion Criteria:

- 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 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 ( (e.g. lesions within brainstem or abutting optic

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

This study aims to determine what the maximum tolerated dose of hypofractionated adaptive stereotactic radiotherapy (HFA-SRT) for recurrent brain metastases is.

Outcome Time Frame:

every 3 months for 3 years

Safety Issue:


Principal Investigator

Caroline Chung, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 08-0602-C



Start Date:

December 2008

Completion Date:

November 2015

Related Keywords:

  • Brain Metastases
  • Brain Metastases
  • Stereotactic radiosurgery (SRS)
  • Hypofractionated stereotactic radiotherapy (HSRT)
  • Recurrent Brain Metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Brain Neoplasms