Brain Cancer Treatment Trial
Phase III Randomized Study of Memantine Hydrochloride in Preventing Cognitive Dysfunction in Patients Undergoing Whole-Brain Radiotherapy for Brain Metastases Secondary to Solid Tumors (RTOG 0614)
Purpose
Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy.
This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- At least 2 weeks but no more than 8 weeks since previous therapy for brain metastases, including radiosurgery or surgical resection
- More than 2 weeks since chemotherapy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will undergo whole-brain radiation therapy 5 days a week for 3 weeks. They will also receive memantine by mouth once-a-day for 24 weeks starting on day 1 of radiation therapy.
- Patients in group two will undergo whole-brain radiation therapy 5 days-a-week for 3 weeks. They will also receive a placebo by mouth once-a-day for 24 weeks starting on day 1 of radiation therapy.
After finishing treatment, patients will be evaluated at 6 months, every 4 months for 1 year, every 6 months for 2 years, and once a year thereafter.