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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Sunnybrook Research Institute | OTHER |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional (i.e. GTR) resection | Other | Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility using eligibility | Measures feasibility. Among all screened patients, the proportion of patients who meet the eligibility criteria | Screening/Enrollment |
| Feasibility using proportion of consent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Farhad Pirouzmand, MD, MSc, FRCSC | Contact | 416-480-6100 | 5263 | farhad.pirouzmand@sunnybrook.ca |
| Ainy Zahid, HBSc. | Contact | 416-480-5631 | ainy.zahid@sunnybrook.ca |
| Name | Affiliation | Role |
|---|---|---|
| Farhad Pirouzmand, MD, MSc, FRCSC | Sunnybrook Health Sciences Centre | Principal Investigator |
| Alireza Mansouri, MD MSc FRCSC | Penn State Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Pennsylvania State University | Recruiting | University Park | Pennsylvania | 16802 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35791008 | Derived | 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. |
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| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D003226 | Congresses as Topic |
| ID | Term |
|---|---|
| D009938 | Organizations |
| D004472 | Health Care Economics and Organizations |
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| Conventional (i.e. GTR) resection | Procedure | Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin. |
|
Measures feasibility. Among all screened patients, the proportion of patients consenting to participate
| Screening/Enrollment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Safety using 6 weeks (+/- 2 weeks) all cause-mortality | Will collect mortality data. | 6 weeks (+/- 2 weeks) post surgery |
| Radiological | Volumetric measurement of contrast enhancement on MRI | 2 (+/- 1) days, 6 months (+/- 2 weeks) and 12 (+/- 1) months |
| Damon Scales, MD, PhD, FRCPC |
| Sunnybrook Health Sciences Centre |
| Principal Investigator |
| Mackenzie Health Sciences Center | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
|
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L 2V7 | Canada |
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| St Michael's Hospital | Recruiting | Toronto | Ontario | M5B 1W8 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | Canada |
|
| University of Saskatchewan | Recruiting | Saskatoon | Saskatchewan | Canada |
|
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |