Spots Global Cancer Trial Database for Enhancing Optune Therapy With Targeted Craniectomy
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Trial Identification
Brief Title: Enhancing Optune Therapy With Targeted Craniectomy
Official Title: Enhancing Optune Therapy of Recurrent Glioblastoma Multiforme Using Targeted Surgical Skull Remodeling
Study ID: NCT02893137
Conditions
Study Description
Brief Summary: The present study proposes a new and potentially superior clinical approach to Optune™ therapy of selected glioblastoma patients. The approach is based on combining TTFields with targeted surgical skull remodeling, such as minor craniectomy or a distribution of burr holes, designed for the individual patient. Pre-clinical modeling results suggest that such procedures may enhance the induced electrical field strength by up to \~100% and thereby potentially improve the clinical outcome of treated patients to a significant extent. The study is an open label phase 1 clinical pilot experiment designed to investigate feasibility, safety and efficacy of the concept. Fifteen patients with first recurrence of glioblastoma will be included in the trial. All patients will receive TTFields therapy with targeted craniotomy and best physician's choice chemotherapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aarhus University Hospital, Aarhus C, Aarhus, Denmark
Contact Details
Name: Anders R Korshoej, MD
Affiliation: Aarhus University Hospital
Role: PRINCIPAL_INVESTIGATOR
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