Perfexion Brain Metastasis

Brain Metastases Clinical Trial

— HF-SRT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805103
• Other study ID #: UHN REB 08-0602-C
• Status: Terminated
• Phase: Phase 1
• First received: December 8, 2008
• Last updated: December 28, 2016
• Start date: December 2008
• Est. completion date: March 2016

Study information

• Verified date: December 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• Pregnant Women

• Men or women of childbearing potential who are unwilling to employ adequate contraception

Study Design

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The secondary outcome will be to evaluate the overall survival and change in tumour response.		every 3 months for 3 years	Yes
Secondary	Measure acute and late toxicities		every 3 months for 3 years	No