Stereotactic Radiosurgery Compared With Hippocampal-Avoidant Whole Brain Radiotherapy (HA-WBRT) Plus Memantine for 5 or More Brain Metastases

Conditions

• Brain Metastases

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Memantine — DRUG
  20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg per week. Memantine should start at 5 mg, and then increased in 5 mg increments at the following schedule, depending on the patient's response and tolerance:
• Hippocampal-avoidant (HA-WBRT) Radiotherapy — RADIATION
  30Gy in 10 fractions
• Stereotactic Radiosurgery (SRS) — PROCEDURE
  18-20 or 22 Gy in single fraction

Study Details

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. Whole brain radiation therapy with hippocampal avoidance (HA-WBRT) is when radiation therapy is given to the whole brain, while trying to decrease the amount of radiation that is delivered to the area of the hippocampus. The hippocampus is a brain structure that is important for memory. Memantine is a drug that is given to help relieve symptoms that can be caused by WBRT, including problems with memory and other mental symptoms. Health Canada, the regulatory body that oversees the use of drugs in Canada, has not approved the sale or use of memantine in combination with WBRT to treat this kind of cancer, although they have allowed its use in this study.

Key Dates

Start date

Nov 22, 2018

Status verified

Apr 2026

Primary completion

Jun 30, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

206 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Hippocampal-avoidant (HA-WBRT) plus Memantine
  WBRT 30Gy in 10 fractions + memantine
• Experimental: Stereotactic Radiosurgery (SRS)
  SRS 18-20 or 22Gy in single fraction

Primary Outcome Measure

Overall Survival [ Time Frame: 4.5 years ]

Central Contacts

• Chris O'Callaghan
  613-533-6430
  [email protected]

Locations (73)

Find similar trials in Tucson, AZ

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