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Compares treatment options for Brain Metastases
Official title Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases
ClinicalTrials.gov ID: NCT03550391
What this study is testing
What is Memantine?
Memantine is an investigational medicine, given as an once-daily, being studied as a potential treatment for brain metastases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Stereotactic radiosurgery (SRS) is a commonly used treatment for brain tumors. It is a one-day (or in some cases two day), out-patient procedure during which a high dose of radiation is delivered to small spots in the brain while excluding the surrounding normal brain.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain...
- 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.
You likely can't join if
- 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 HA-WBRT.
See the full eligibility 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 and HA-WBRT. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre...
- 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...
- 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 assigned by chance on this trial will be available for complete documentation of the treatment, adverse events...
- 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.
- 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 HA-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...
- 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).
- Patients with architectural distortion of lateral ventricular systems, which, in the opinion of the local investigator, makes hippocampal delineation challenging
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Corona, California, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Orange, California, United States
- Rancho Cordova, California, United States
- Rohnert Park, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- Santa Clara, California, United States
- South Pasadena, California, United States
- South San Francisco, California, United States
- Torrance, California, United States
- Upland, California, United States
- Boca Raton, Florida, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Hollywood, Florida, United States
+ 57 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Corona, California, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Lancaster, California, United States and 71 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.