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Spots Global Cancer Trial Database for Glioma Supra Marginal Incision Trial

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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