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Glioma Supra Marginal Incision Trial (G-SUMIT)

Primary Purpose

High Grade Glioma

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Supramarginal resection

Conventional (i.e. GTR) resection

About this trial

This is an interventional other trial for High Grade Glioma focused on measuring Supramarginal resection, Standard total resection, Surgery, Brain tumor, HGG

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;
Age ≥18 ≤ 80 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.

Exclusion Criteria:

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);
Intraoperative histopathological diagnosis not consistent with HGG;
Known metastatic cancer;
Uncorrectable coagulopathy;
Unable to obtain GAD-enhanced brain MRI.

Sites / Locations

The Pennsylvania State UniversityRecruiting
Mackenzie Health Sciences CenterRecruiting
Kingston Health Sciences CentreRecruiting
St Michael's HospitalRecruiting
Sunnybrook Health Sciences CentreRecruiting
University of SaskatchewanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Supramarginal resection (intervention arm)

Conventional (i.e. GTR) resection

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Enrollment

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

Secondary Outcome Measures

Feasibility using eligibility

Measures feasibility. Among all screened patients, the proportion of patients who meet the eligibility criteria

Feasibility using proportion of consent

Measures feasibility. Among all screened patients, the proportion of patients consenting to participate

Feasibility using number of completed visits

Measures feasibility. Among all screened patients, the proportion of patients completing all scheduled follow-up assessments

Feasibility using Gross Total Resection

Measures feasibility. The proportion of radiographically-confirmed gross total resection of contrast-enhancing tumor based on the first MRI after surgery.

Efficacy using overall survival

Measures efficacy. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries.

Efficacy using progression-free survival

Measures efficacy. Assessment of progression-free survival based on the Modified Criteria for Radiographic Response Assessment in Glioblastoma (mRANO) criteria. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries. Progression-free survival will be measured based on mRANO criteria during regular 3-month interval clinical and MRI follow up

Safety using neurological function

The NIH Stroke Scale (NIHSS) will be used to assess neurological function. The NIHSS is a validated neurologically-specific outcome tool originally developed for rapid grading of stroke symptoms adopted in surgical clinical trials as well.

Safety using global disability

The modified rankin scale (mRS ) is a measure of global disability that has been widely used to assess outcome after stroke. The scale consists of six grades from 0 (no symptoms) to 5 (severe disability); 6 indicates death.

Safety using quality of life

The overall quality of life will be assessed either in-person or over the phone using the EuroQol-5 (EQ-5D). The EQ-5D is a generic instrument used to measure quality of life, designed for self-completion by respondents either face-to-face or over telephone interview, also available in proxy version through care giver.

Safety using 6 weeks (+/- 2 weeks) all cause-mortality

Will collect mortality data.

Radiological

Volumetric measurement of contrast enhancement on MRI

Full Information

NCT ID

NCT04737577

First Posted

January 19, 2021

Last Updated

June 15, 2023

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04737577

Brief Title

Glioma Supra Marginal Incision Trial

Acronym

G-SUMIT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 5, 2021 (Actual)

Primary Completion Date

February 2025 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

High Grade Glioma

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Supramarginal resection (intervention arm)

Arm Type

Experimental

Arm Description

Arm Title

Conventional (i.e. GTR) resection

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Supramarginal resection

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Conventional (i.e. GTR) resection

Intervention Description

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

Primary Outcome Measure Information:

Title

Enrollment

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Feasibility using eligibility

Description

Measures feasibility. Among all screened patients, the proportion of patients who meet the eligibility criteria

Time Frame

Screening/Enrollment

Title

Feasibility using proportion of consent

Description

Measures feasibility. Among all screened patients, the proportion of patients consenting to participate

Time Frame

Screening/Enrollment

Title

Feasibility using number of completed visits

Description

Measures feasibility. Among all screened patients, the proportion of patients completing all scheduled follow-up assessments

Time Frame

Through study completion, on average 2 years

Title

Feasibility using Gross Total Resection

Description

Measures feasibility. The proportion of radiographically-confirmed gross total resection of contrast-enhancing tumor based on the first MRI after surgery.

Time Frame

2 days (+/- 1 day) post surgery

Title

Efficacy using overall survival

Description

Measures efficacy. The date of death will be obtained from hospital records, outpatient follow up clinic notes, or provincial cancer registries.

Time Frame

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

Title

Efficacy using progression-free survival

Description

Time Frame

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

Title

Safety using neurological function

Description

Time Frame

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

Title

Safety using global disability

Description

Time Frame

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

Title

Safety using quality of life

Description

Time Frame

6 months (+/- 2 weeks) and 12 (+/- 4 weeks) post surgery, 24 (+/- 4 weeks) post surgery

Title

Safety using 6 weeks (+/- 2 weeks) all cause-mortality

Description

Will collect mortality data.

Time Frame

6 weeks (+/- 2 weeks) post surgery

Title

Radiological

Description

Volumetric measurement of contrast enhancement on MRI

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Farhad Pirouzmand, MD, MSc, FRCSC

Phone

416-480-6100

Ext

5263

farhad.pirouzmand@sunnybrook.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Ainy Zahid, HBSc.

Phone

416-480-5631

ainy.zahid@sunnybrook.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Farhad Pirouzmand, MD, MSc, FRCSC

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alireza Mansouri, MD MSc FRCSC

Organizational Affiliation

Penn State Cancer Institute

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Damon Scales, MD, PhD, FRCPC

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Pennsylvania State University

City

University Park

State/Province

Pennsylvania

ZIP/Postal Code

16802

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ann Needles, BSc

Phone

717-531-0003

Ext

283114

aneedles@pennstatehealth.psu.edu

First Name & Middle Initial & Last Name & Degree

Seyed A Manouri, MD

Facility Name

Mackenzie Health Sciences Center

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathew Mossey

mmossey@ualberta.ca

First Name & Middle Initial & Last Name & Degree

Cian OKelly, MD

Facility Name

Kingston Health Sciences Centre

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Craig Spencer

Craig.Spencer@kingstonhsc.ca

First Name & Middle Initial & Last Name & Degree

Teresa Purzner, MD

Facility Name

St Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clementine k Affana

Clementine.KoaAffana@unityhealth.to

First Name & Middle Initial & Last Name & Degree

Sunit Das, MD

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Farhad Pirouzmand, MD, MSc, FRCSC

Phone

416-480-6100

Ext

5263

farhad.pirouzmand@sunnybrook.ca

Facility Name

University of Saskatchewan

City

Saskatoon

State/Province

Saskatchewan

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jessica Grosskleg

Phone

jessica.grosskleg@usask.ca

First Name & Middle Initial & Last Name & Degree

Michael Kelly, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

35791008

Citation

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.

Results Reference

derived

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Glioma Supra Marginal Incision Trial

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