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
Abstract Background High-grade gliomas are the most common primary malignant brain tumor in adults having a median survival of only 13–16 months. This is despite the current standard of maximal safe surgical resection followed by fractionated radiotherapy and chemotherapy. Extending the tumor resect...
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| Format: | Article |
| Language: | English |
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BMC
2022-07-01
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| Series: | Pilot and Feasibility Studies |
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| Online Access: | https://doi.org/10.1186/s40814-022-01104-1 |
| _version_ | 1818158598576930816 |
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| author | Alireza Mansouri Carolyn Lai Damon Scales Farhad Pirouzmand |
| author_facet | Alireza Mansouri Carolyn Lai Damon Scales Farhad Pirouzmand |
| author_sort | Alireza Mansouri |
| collection | DOAJ |
| description | Abstract Background High-grade gliomas are the most common primary malignant brain tumor in adults having a median survival of only 13–16 months. This is despite the current standard of maximal safe surgical resection followed by fractionated radiotherapy and chemotherapy. Extending the tumor resection limit beyond the gadolinium (GAD)-enhancing margin (i.e., supra-marginal resection) could in principle provide an added survival benefit as it has been shown that > 80% of post-operative tumor recurrence is within a 2-cm region surrounding the original GAD-enhancing margin. However, this must be weighed against the risk of potential damage to functional brain tissue. Methods In this phase II pilot randomized control trial (RCT), we aim to assess the feasibility of “supra-marginal” resection extending 1 cm beyond the enhancing tumor in adults with radiographic evidence of GAD-enhancing intra-axial tumor consistent with high-grade glioma in a safe anatomical location and a Karnofsky Performance Score > 60. With six academic institutions with established neurosurgical oncology practices in participation, we aim to enroll 72 patients over 2 years. Primary outcomes include evaluating the feasibility of performing a large-scale trial with regard to recruitment, allocation, and outcome documentation as well as safety data. Secondary outcomes include determining if there is an increased survival benefit with supra-marginal resection and impact on quality of life (Modified Rankin Scale (mRS), EuroQol-5D (ED-5D), 30-day all-cause mortality). Discussion Recent studies have revealed survival advantages comparing supra-marginal resection to standard attempt at gross total resection (GTR) with no additional perioperative surgical risk; however, the current quality of evidence is low and under-powered. Therefore, there are no current practice guidelines, and the philosophy of surgical resection is guided by individual surgeon preferences on an individual patient basis. This creates additional uncertainty and is potentially detrimental to our patients. This clinical equipoise supports the need for an adequately powered RCT to determine whether a supra-marginal resection can have a positive impact on survival for patients with HGGs. Our pilot RCT will test the feasibility of comparing the standard gross total resection of GAD-enhancing tumors and supra-marginal resection to prepare for a larger definitive multicenter RCT. Trial registration ClinicalTrials.gov , NCT04737577. Registered on February 4, 2021 |
| first_indexed | 2024-12-11T15:32:38Z |
| format | Article |
| id | doaj.art-944bc925000f4cdda13c47186b6c5f3d |
| institution | Directory Open Access Journal |
| issn | 2055-5784 |
| language | English |
| last_indexed | 2024-12-11T15:32:38Z |
| publishDate | 2022-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Pilot and Feasibility Studies |
| spelling | doaj.art-944bc925000f4cdda13c47186b6c5f3d2022-12-22T01:00:01ZengBMCPilot and Feasibility Studies2055-57842022-07-018111110.1186/s40814-022-01104-1A 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 protocolAlireza Mansouri0Carolyn Lai1Damon Scales2Farhad Pirouzmand3Department of Neurosurgery, Penn State UniversitySunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of TorontoSunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of TorontoSunnybrook Health Sciences Centre, Sunnybrook Research Institute, University of TorontoAbstract Background High-grade gliomas are the most common primary malignant brain tumor in adults having a median survival of only 13–16 months. This is despite the current standard of maximal safe surgical resection followed by fractionated radiotherapy and chemotherapy. Extending the tumor resection limit beyond the gadolinium (GAD)-enhancing margin (i.e., supra-marginal resection) could in principle provide an added survival benefit as it has been shown that > 80% of post-operative tumor recurrence is within a 2-cm region surrounding the original GAD-enhancing margin. However, this must be weighed against the risk of potential damage to functional brain tissue. Methods In this phase II pilot randomized control trial (RCT), we aim to assess the feasibility of “supra-marginal” resection extending 1 cm beyond the enhancing tumor in adults with radiographic evidence of GAD-enhancing intra-axial tumor consistent with high-grade glioma in a safe anatomical location and a Karnofsky Performance Score > 60. With six academic institutions with established neurosurgical oncology practices in participation, we aim to enroll 72 patients over 2 years. Primary outcomes include evaluating the feasibility of performing a large-scale trial with regard to recruitment, allocation, and outcome documentation as well as safety data. Secondary outcomes include determining if there is an increased survival benefit with supra-marginal resection and impact on quality of life (Modified Rankin Scale (mRS), EuroQol-5D (ED-5D), 30-day all-cause mortality). Discussion Recent studies have revealed survival advantages comparing supra-marginal resection to standard attempt at gross total resection (GTR) with no additional perioperative surgical risk; however, the current quality of evidence is low and under-powered. Therefore, there are no current practice guidelines, and the philosophy of surgical resection is guided by individual surgeon preferences on an individual patient basis. This creates additional uncertainty and is potentially detrimental to our patients. This clinical equipoise supports the need for an adequately powered RCT to determine whether a supra-marginal resection can have a positive impact on survival for patients with HGGs. Our pilot RCT will test the feasibility of comparing the standard gross total resection of GAD-enhancing tumors and supra-marginal resection to prepare for a larger definitive multicenter RCT. Trial registration ClinicalTrials.gov , NCT04737577. Registered on February 4, 2021https://doi.org/10.1186/s40814-022-01104-1High-grade gliomasSupra-marginal resectionMalignant brain tumor |
| spellingShingle | Alireza Mansouri Carolyn Lai Damon Scales Farhad Pirouzmand 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 and Feasibility Studies High-grade gliomas Supra-marginal resection Malignant brain tumor |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | High-grade gliomas Supra-marginal resection Malignant brain tumor |
| url | https://doi.org/10.1186/s40814-022-01104-1 |
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