Glioma Supra Marginal Incision Trial

High Grade Glioma Clinical Trial

— G-SUMIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737577
• Other study ID #: CTO 3297
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2021
• Est. completion date: February 2025

Study information

• Verified date: June 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Farhad Pirouzmand, MD, MSc, FRCSC
• Phone: 416-480-6100
• Email: farhad.pirouzmand[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Radiographic evidence of a GAD-enhancing intra-axial tumor consistent with HGG;

2. Age =18 = 85 years;

3. Karnofsky Performance Score = 60;

4. Location of tumor in a safe anatomical location and

5. Patient or substitute decision maker (SDM) able to understand and consent to study participation.

Exclusion Criteria:

1. Multi-focal tumor, gliomatosis cerebri (=3 lobes of the brain affected), tumors crossing the midline, or leptomeningeal enhancement;

2. Previous craniotomy for tumor excision (stereotactic biopsy is permitted);

3. Known metastatic cancer;

4. Uncorrectable coagulopathy;

5. Unable to obtain GAD-enhanced brain MRI.

Related Conditions & MeSH terms

• Glioma
• High Grade Glioma

Intervention

Procedure:
• Supramarginal resection
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.
• Conventional (i.e. GTR) resection
Planned resection of =95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.

Locations

Country	Name	City	State
Canada	Mackenzie Health Sciences Center	Edmonton	Alberta
Canada	Kingston Health Sciences Centre	Kingston	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	St Michael's Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR), Sunnybrook Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility using eligibility	Measures feasibility. Among all screened patients, the proportion of patients who meet the eligibility criteria	Screening/Enrollment
Secondary	Feasibility using proportion of consent	Measures feasibility. Among all screened patients, the proportion of patients consenting to participate	Screening/Enrollment
Secondary	Feasibility using number of completed visits	Measures feasibility. Among all screened patients, the proportion of patients completing all scheduled follow-up assessments	Through study completion, on average 2 years
Secondary	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.	2 days (+/- 1 day) post surgery
Secondary	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.	6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
Secondary	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	6 weeks (+/- 2 weeks), 6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
Secondary	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.	2 (+/- 1) days and 6 weeks (+/- 2 weeks), days post surgery
Secondary	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.	6 months (+/- 2 weeks) and 12 (+/- 1) months post surgery
Secondary	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.	6 months (+/- 2 weeks) and 12 (+/- 4 weeks) post surgery, 24 (+/- 4 weeks) post surgery
Secondary	Safety using 6 weeks (+/- 2 weeks) all cause-mortality	Will collect mortality data.	6 weeks (+/- 2 weeks) post surgery
Secondary	Radiological	Volumetric measurement of contrast enhancement on MRI	2 (+/- 1) days, 6 months (+/- 2 weeks) and 12 (+/- 1) months