About the Alliance for Clinical Trials in Oncology
The AANS/CNS Tumor Section has implemented a collaboration with the Alliance for Clinical Trials in Oncology to facilitate cooperative efforts between neurosurgeons, neuro-oncologists and radiation oncologists at the national level to more efficiently support neuro-oncology clinical trials. Each issue of the Tumor Section Newsletter will highlight a clinical trial that is being sponsored by the Alliance or presented at one of the semi-annual meetings and may be of interest to neurosurgeons. Additional information regarding the Alliance is available on the website.
Clinical trials highlighted in prior newsletters included:
- Phase I/Comparative Randomized Phase II Trial of TRC105 Plus Bevacizumab Versus Bevacizumab in Bevacizumab-Naïve Patients With Recurrent Glioblastoma Multiforme
- PI: Evanthia Galanis, MD, Mayo Clinic
- A phase II/III randomized trial of veliparib or placebo in combination with adjuvant temozolomide in newly diagnosed glioblastoma with MGMT promotor hypermethylation
- PI: Jann Sarkaria, MD, Mayo Clinic
- Phase II trial of SMO/AKT/NF2 inhibitors in progressive meningiomas with SMO/AKT/NF2 mutations
- PI: Priscilla Brastianos, MD, Massachusetts General Hospital
The clinical trial highlighted in this report is “Stereotactic Radiosurgery compared with whole brain radiotherapy (WBRT) for 5-15 brain metastases.” The role of Stereotactic Radiosurgery (SRS) in treating less than five metastases is clearer, and clinical studies have demonstrated superior results to WBRT in terms of neurocognitive side effects. The use of SRS in treating a larger number of brain metastases is more controversial. Neurosurgeons who routinely see patients with brain metastases will be interested in this trial, as it influences treatment paradigms offered to patients.
This phase 3 clinical trial will enroll patients with 5-15 non-hematopoietic brain metastases. All brain metastases will be less than 2.5 cm in maximal diameter. Patients will be randomized to:
- Arm A: WBRT (30Gy in 10 fractions) + memantine
- Arm B: SRS (18-20 Gy hypofractionated or 22Gy single fraction)
Primary outcome measures:
- Compare overall survival between the two treatment arms
- Compare neurocognitive PFS between the two treatment arms
- Time to CNS progression
- Differences in CNS failure patterns
- Number of salvage procedures following SRS compared to WBRT
The estimated enrollment is 206 patients. The PI is Michael Chan, MD, FAANS, at Wake Forest. Further information regarding this clinical trial is on the Alliance website at allianceforclinicaltrialsinoncology.org or at clinicaltrials.gov. A list of ongoing trials sponsored by the Alliance can be accessed via the Alliance website as well.
The spring Alliance for Clinical Trials in Oncology meeting is Saturday, May 11, 2019 in Chicago.