Clinical Trials and Registries

Chair, Co-Chair: Brad Elder, MD, and Gavin Dunn, MD
Members: Dan Cahill, MD, Melanie Hayden Gephart, MD,
Mark Linskey, MD, Timothy Smith, MD, Andrew Sloan, MD,
and Michael Vogelbaum, MD

 

From the “Clinical Trials and Registries” sub-committee, we are excited to provide updates on important tumor registry and highlight clinical trial activity.

Most importantly, we prepared a survey to be circulated among all tumor neurosurgeons regarding the NeuroPoint Alliance (NPA)and national clinical trial consortia. This survey focuses on

helping the Tumor Section identify ways to strengthen neurosurgeon involvement in these national committees. We are targeting maximal engagement and kept the survey short. If you would like to participate, please email Brad Elder at brad.elder@osumc.edu

 

Alliance for Clinical Trials in Oncology

In this report, we highlight an Alliance study, “Single Fraction Stereotactic Radiosurgery Compared with Fractionated Stereotactic Radiosurgery in Treating Patients with Resected Metastatic Brain Disease.” Inclusion criteria are patients with resected brain metastasis from a non-CNS primary site and three or fewer unresected brain metastases at the time of screening. Unresected tumors must measure < 4.0 cm in maximal diameter. One (and only one) brain metastasis must have been completely (GTR) resected within 30 days of registration. Primary outcome is surgical bed recurrence-free survival. Target enrollment is 208 patients. PI is Paul Brown, MD.

Further information regarding this clinical trial can be obtained from the Alliance website at allianceforclinicaltrialsinoncology.org or clinicaltrials.gov. A list of ongoing trials sponsored by the Alliance can be accessed via the Alliance website.

The spring Alliance for Clinical Trials in Oncology meeting is a virtual meeting May 3-6, 2023, in Chicago, Illinois.

 

NeuroPoint Alliance

NPA was established in 2008 to improve quality of care for neurosurgical patients through the acquisition and analysis of clinical outcomes data. The goals of the NPA include:

  • Establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical and spine procedures.
  • Allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real-time.
  • Generate both quality and efficacy data to support claims made to public and private payers.
  • Demonstrate the comparative effectiveness of neurosurgical procedures.
  • Facilitate essential multi-center trials and other cooperative clinical studies.

o   Data has supported production of >100 manuscripts.

 

Tumor QOD:

The NPA QOD Tumor Registry was developed in collaboration with the AANS/CNS Tumor Section Executive Committee and opened in April 2021 after a one-year pilot study. The Tumor Registry focuses on outcomes for intracranial tumor procedures. Participating sites enter outcomes data online through RedCap. Mayo Clinic is the coordinating center and provides data management, analysis and clinical and scientific guidance. The QOD Tumor Registry Steering Committee convened in 2021 provides strategic direction of the registry, provides content expertise, guidance, and promotion of program activities. A quarterly report is provided to enrolling centers which gives a breakdown of demographics, case mix and outcomes in comparison to overall tumor registry data.

Tumor Registry Steering Committee: E. Antonio Chiocca (chair), Mark Shaffrey (NPA Data Operations Committee), Timothy Smith (NPA Data Use Committee), Randy Jensen (Tumor Section), Linda Liau (NREF), Shawn Hervey-Jumper (Young Neurosurgeons Committee), Fred Barker (NPA Board of Directors), Carl Heilman (key opinion leader)

 Participating in the Tumor QOD registry

Participating institutes can include academic medical centers, hospitals, ambulatory surgery centers, health care systems, private practice groups and individual surgeons. The startup process includes registration, training and onboarding, and is followed by continuous site support and monitoring.

The current price point is three-year contract with $5,000/year registration fees plus funding of a 0.5 FTE for data entry. The number of centers active and in contract increasing.

Those interested in more information regarding participating in the NPA Tumor QOD should contact: Irene Zyung, senior manager, Registry Operations, Email: izyung@neuropoint.org

Phone: 847-378-0549