Clinical Studies Search

Protocol Summary

Protocol No.
Prinicipal Investigator
Mansouri, Seyed Alireza
Phase II
Age Group
Phase II Pilot RCT to assess feasibility of supra-marginal surgical resection of malignant glioma (G-SUMIT: Glioma Supra Marginal Incision Trial)
Primary Objective: To evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for
first-time diagnosis of HGG in a surgically favourable anatomical location. Specifically: to establish ability to meet pre-specified criteria in identification, recruitment, allocation and outcome documentation process during trial; to confirm suitability of implementing the study in multiple experienced and well-resourced centres, and to optimize inclusion/exclusion criteria for better recruitment, retention, refinement of outcome definition and estimates of the baseline rates of the safety and effectiveness outcomes in larger trial.

Secondary Objective(s): To determine whether extending margin of resection 1 cm beyond visible enhanced volume on MR image result in: increased overall survival; similar rate of clinically-significant neurological worsening during 30 days post surgery and quality of life (QOL) at 6 and 12 months.
Applicable Disease Sites
Brain and Nervous System
Participating Institutions
Hershey Medical Center