The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Glioma Supra Marginal Incision Trial
Official Title: Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma
Study ID: NCT04737577
Brief Summary: G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following: Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?
Detailed Description: This pilot, multi-centre, pragmatic randomized controlled trial is planned to simulate all aspects of a larger definitive trial comparing conventional versus supramarginal tumor resection at the time of the first surgical resection of HGG in appropriately selected patients. This pilot will help determine the ability to meet pre-specified criteria in identification, recruitment, and patient allocation, allow for refinement of eligibility criteria for optimal recruitment, confirm safety of procedure and ability to retain participants for the duration of the trial. Preliminary efficacy data will inform sample size calculations and estimation of resources required for the envisioned larger definitive trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Pennsylvania State University, University Park, Pennsylvania, United States
Mackenzie Health Sciences Center, Edmonton, Alberta, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
St Michael's Hospital, Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Name: Farhad Pirouzmand, MD, MSc, FRCSC
Affiliation: Sunnybrook Health Sciences Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Alireza Mansouri, MD MSc FRCSC
Affiliation: Penn State Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Damon Scales, MD, PhD, FRCPC
Affiliation: Sunnybrook Health Sciences Centre
Role: PRINCIPAL_INVESTIGATOR