Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-23-142
Prinicipal Investigator
Zacharia, Brad
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
SC9-GBM-03
Title
A Randomized, Open-label, Multicentric, Two-arm Pivotal Trial of SonoCloud-9 Combined With Carboplatin (CBDCA) vs Standard of Care Lomustine (CCNU) or Temozolomide (TMZ) in Patients Undergoing Planned Resection for First Recurrence Glioblastoma
Objective
Primary Objective: to evaluate and compare the survival outcome of patients with first recurrence of glioblastoma undergoing surgical debulking/resection followed by either implantation of the SC9 device and repeat BBB opening in association with carboplatin chemotherapy or standard of care 2nd line chemotherapy with either lomustine or temozolomide (per best physician's choice and best practice).
Applicable Disease Sites
Brain and Nervous System
Status
Open
Participating Institutions
Hershey Medical Center