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Perfexion Brain Metastasis (HF-SRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00805103
Recruitment Status : Terminated
First Posted : December 9, 2008
Last Update Posted : December 29, 2016
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Radiation: Hypofractionated stereotactic radiotherapy Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Stereotactic Radiotherapy (HF-SRT) for Large-Volume Brain Metastases
Study Start Date : December 2008
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: (HFA-SRT) in Large-Volume Brain Metastases Radiation: Hypofractionated stereotactic radiotherapy
Patients will be initially administered 8 Gy RT (level). The dose at each level will be increase by 2 Gy up to level 4. If ≥ 2 of the patients in a dose cohort encounter a DLT, then that dose level will be declared the maximum administered dose. An additional 3 patients will then be entered at the previous dose level and provided no more than one patient experiences a DLT, that level will be declared the maximum tolerated dose (MTD). Up to 6 more patients can be treated at the given dose level while awaiting the results of 6 months of follow-up.

Primary Outcome Measures :
  1. This study aims to determine what the maximum tolerated dose of hypofractionated adaptive stereotactic radiotherapy (HFA-SRT) for recurrent brain metastases is. [ Time Frame: every 3 months for 3 years ]

Secondary Outcome Measures :
  1. The secondary outcome will be to evaluate the overall survival and change in tumour response. [ Time Frame: every 3 months for 3 years ]
  2. Measure acute and late toxicities [ Time Frame: every 3 months for 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00805103

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Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
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Principal Investigator: Caroline Chung, MD University Health Network, Princess Margaret Hospital
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Responsible Party: University Health Network, Toronto Identifier: NCT00805103    
Other Study ID Numbers: UHN REB 08-0602-C
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: December 29, 2016
Last Verified: December 2016
Keywords provided by University Health Network, Toronto:
Brain Metastases
Stereotactic radiosurgery (SRS)
Hypofractionated stereotactic radiotherapy (HSRT)
Recurrent Brain Metastases
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases