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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00805103
Other study ID # UHN REB 08-0602-C
Secondary ID
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


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
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