Glioma Supra Marginal Incision Trial

NCT04737577 | Unknown DMC

• 1 other identifier: CTO 3297
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 6

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?

Conditions

High Grade Glioma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Enrollment

  The number of patients enrolled and successfully allocated to the intervention versus the control treatment

  Collected at time of randomization, through end of enrollment period (2 years)

Secondary Outcomes (11)

• Feasibility using eligibility

  Screening/Enrollment

• Feasibility using proportion of consent

  Screening/Enrollment

• Feasibility using number of completed visits

  Through study completion, on average 2 years

• Feasibility using Gross Total Resection

  2 days (+/- 1 day) post surgery

• Efficacy using overall survival

  6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery

Study Arms (2)

Supramarginal resection (intervention arm)

EXPERIMENTAL

Planned resection beyond the Gadolinium (GAD)-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.

Procedure: Supramarginal resection

Conventional (i.e. GTR) resection

OTHER

Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.

Procedure: Conventional (i.e. GTR) resection

Interventions

Supramarginal resection PROCEDURE

Tissue removal beyond the GAD-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.

Supramarginal resection (intervention arm)

Conventional (i.e. GTR) resection PROCEDURE

Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.

Conventional (i.e. GTR) resection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
• Age ≥18 ≤ 85 years;
• Karnofsky Performance Score ≥ 60;
• Location of tumor in a safe anatomical location and
• Patient or substitute decision maker (SDM) able to understand and consent to study participation.

You may not qualify if:

• Multi-focal tumor, gliomatosis cerebri (≥3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;
• Previous craniotomy for tumor excision (stereotactic biopsy is permitted);
• Known metastatic cancer;
• Uncorrectable coagulopathy;
• Unable to obtain GAD-enhanced brain MRI.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Sunnybrook Research Institute: collaborator

Study Sites (6)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

RECRUITING

Mackenzie Health Sciences Center

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

RECRUITING

Related Publications (1)

• Mansouri A, Lai C, Scales D, Pirouzmand F. A phase II pilot randomized controlled trial to assess the feasibility of the "supra-marginal" surgical resection of malignant glioma (G-SUMIT: Glioma supra marginal incision trial) study protocol. Pilot Feasibility Stud. 2022 Jul 5;8(1):138. doi: 10.1186/s40814-022-01104-1.

  PMID: 35791008 DERIVED

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Farhad Pirouzmand, MD, MSc, FRCSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Alireza Mansouri, MD MSc FRCSC

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

• Damon Scales, MD, PhD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farhad Pirouzmand, MD, MSc, FRCSC

CONTACT

416-480-6100; farhad.pirouzmand@sunnybrook.ca

Ainy Zahid, HBSc.

CONTACT

416-480-5631; ainy.zahid@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 4, 2021
• Study Start: February 5, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

CA (5); US (1)