Perfexion Brain Metastasis - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00805103

Purpose

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	Intervention	Phase
Brain Metastases	Radiation: Hypofractionated stereotactic radiotherapy	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Hypofractionated and Adaptive Stereotactic Radiotherapy (HFA-SRT) for Large-Volume Brain Metastases

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome will be to evaluate the overall survival and change in tumour response. [ Time Frame: every 3 months for 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	December 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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 (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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805103

Contacts

Contact: Cynthia Ménard, MD

416 946 4501 ext 6513

cynthia.menard@rmp.uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Cynthia Ménard, MD 416-946-4501 ext 6513 cynthia.menard@rmp.uhn.on.ca
Principal Investigator: Cynthia Ménard, MD

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Cynthia Ménard, MD

University Health Network, Princess Margaret Hospital

More Information

Responsible Party:	University Health Network, Princess Margaret Hospital ( Dr. Cynthia Ménard, Staff Radiation Oncology, Clinician Scientist )
Study ID Numbers:	UHN REB 08-0602-C
Study First Received:	December 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00805103
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Brain Metastases
Stereotactic radiosurgery (SRS)
Hypofractionated stereotactic radiotherapy (HSRT)
Recurrent Brain Metastases

Study placed in the following topic categories:

Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases
Central Nervous System Neoplasms

Brain Diseases
Nervous System Neoplasms
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009