Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03550391 : Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI
obtained = 30 days from randomization (maximum 15 brain metastases).

- Patients must have a pathological diagnosis (cytological or histological) of a
non-hematopoietic malignancy.

- The largest brain metastasis must measure <2.5 cm in maximal diameter.

- Centre must have the ability to treat patients with either a Gamma Knife, Cyberknife,
or a linear accelerator-based radiosurgery system.

- Patient must be > 18 years of age.

- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life
questionnaires in either English or French either alone or with assistance.

- ECOG performance status 0, 1, or 2.

- Creatinine clearance must be = 30 ml/min within 28 days prior to registration.

- The Neurocognitive Testing examiner must have credentialing confirming completion of
the neurocognitive testing training.

- Facility is credentialed by IROC to perform SRS. The treating centre must have
completed stereotactic radiosurgery credentialing of the specific system(s) to be used
in study patients.

- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrolment in
the trial to document their willingness to participate.

- A similar process must be followed for sites outside of Canada as per their respective
cooperative group's procedures.

- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.

- In accordance with CCTG policy, protocol treatment is to begin within 14 days of
patient enrolment.

- Women/men of childbearing potential must have agreed to use a highly effective
contraceptive method.

Exclusion Criteria:

- Pregnant or nursing women.

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

- Inability to complete a brain MRI.

- Known allergy to gadolinium.

- Prior cranial radiation therapy.

- Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or WBRT.

- Primary germ cell tumour, small cell carcinoma, or lymphoma.

- Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy,
leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on
imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF)
positive for tumour cells.

- A brain metastasis that is located = 5 mm of the optic chiasm or either optic nerve.

- Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).

- More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm or
smaller) performed within the past 14 days, or more than 10 metastases in the case of
a non-volumetric MRI.

- Prior allergic reaction to memantine.

- Current alcohol or drug abuse.

- Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.

- Diagnosis of chronic liver disease/cirrhosis of the liver (e.g. Child-Pugh class B or
C).
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03550391      |      Link to official Clinicaltrials.gov listing
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