CCTG CE7

Clinical Trial Title A Phase III Trial of Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases
Trial Status Open to Enrollment
Start Date 05/25/2018
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Brain Metastases
Description

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.
Eligibility Criteria

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.
  • ECOG performance status 0, 1, or 2.

Ineligibility Criteria

  • Pregnant or nursing women.
  • Inability to complete a brain MRI.
  • Prior cranial radiation therapy.
  • Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
  • 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).

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes  https://clinicaltrials.gov/ct2/show/NCT03550391?term=cctg+ce.7
Principal Investigator Andrew Kee, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org