RECRUITING

Glioma Supra Marginal Incision Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Phase II Pilot Randomized Controlled Trial to Assess Feasibility of "Supra-marginal" Surgical Resection of Malignant Glioma

Quick Facts

Study Start:2021-02-05
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04737577

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
  2. 2. Age ≥18 ≤ 85 years;
  3. 3. Karnofsky Performance Score ≥ 60;
  4. 4. Location of tumor in a safe anatomical location and
  5. 5. Patient or substitute decision maker (SDM) able to understand and consent to study participation.
  1. 1. Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
  2. 2. Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
  3. 3. Known metastatic cancer;
  4. 4. Uncorrectable coagulopathy;
  5. 5. Unable to obtain GAD-enhanced brain MRI.

Contacts and Locations

Study Contact

Farhad Pirouzmand, MD, MSc, FRCSC
CONTACT
416-480-6100
farhad.pirouzmand@sunnybrook.ca
Ainy Zahid, HBSc.
CONTACT
416-480-5631
ainy.zahid@sunnybrook.ca

Principal Investigator

Farhad Pirouzmand, MD, MSc, FRCSC
PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre
Alireza Mansouri, MD MSc FRCSC
PRINCIPAL_INVESTIGATOR
Penn State Cancer Institute
Damon Scales, MD, PhD, FRCPC
PRINCIPAL_INVESTIGATOR
Sunnybrook Health Sciences Centre

Study Locations (Sites)

The Pennsylvania State University
University Park, Pennsylvania, 16802
United States

Collaborators and Investigators

Sponsor: Sunnybrook Health Sciences Centre

  • Farhad Pirouzmand, MD, MSc, FRCSC, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Centre
  • Alireza Mansouri, MD MSc FRCSC, PRINCIPAL_INVESTIGATOR, Penn State Cancer Institute
  • Damon Scales, MD, PhD, FRCPC, PRINCIPAL_INVESTIGATOR, Sunnybrook Health Sciences Centre

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-05
Study Completion Date2025-02

Study Record Updates

Study Start Date2021-02-05
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • Supramarginal resection
  • Standard total resection
  • Surgery
  • Brain tumor
  • HGG

Additional Relevant MeSH Terms

  • High Grade Glioma