Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118723
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-10-12
Brief Title:
The SUPRAMAX Study Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients ENCRAM 2201
Sponsor:
Jasper Gerritsen
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The SUPRAMAX-study Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients ENCRAM 2201
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUPRAMAX
Brief Summary:
A greater extent of resection of the contrast-enhancing CE tumor part has been associated with improved outcomes in high-grade glioma patients Recent results suggest that resection of the non-contrast-enhancing NCE part might yield even better survival outcomes supramaximal resection SMR Therefore this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival functional neurological cognitive and quality of life outcomes Furthermore it evaluates which patients benefit the most from SMR and how they could be identified preoperatively
This study is an international multicenter prospective 2-arm cohort study of observational nature Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 13 ratio Primary endpoints are 1 overall survival and 2 proportion of patients with NIHSS National Institute of Health Stroke Scale deterioration at 6 weeks 3 months and 6 months postoperatively Secondary endpoints are 1 residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2 progression-free survival 3 onco-functional outcome and 4 quality of life at 6 weeks 3 months and 6 months postoperatively
The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping ENCRAM
This study is an international multicenter prospective 2-arm cohort study of observational nature Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 13 ratio Primary endpoints are 1 overall survival and 2 proportion of patients with NIHSS National Institute of Health Stroke Scale deterioration at 6 weeks 3 months and 6 months postoperatively Secondary endpoints are 1 residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2 progression-free survival 3 onco-functional outcome and 4 quality of life at 6 weeks 3 months and 6 months postoperatively
The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping ENCRAM
Detailed Description:
This is an international multicenter prospective observational 2-arm cohort study registration clinicaltrialsgov ID number TBA Eligible patients are operated with supramaximal resection versus maximal resection with a 13 ratio with a sequential computer-generated random number as subject ID Intraoperative mapping techniques andor surgical adjuncts can be used in both treatment arms to ensure the safety of the resection to minimize the risk of postoperative deficits Supramaximal resection is defined as 0 cm3 CE tumor and 5 cm3 or less NCE tumor whereas maximal resection is defined as 0 cm3 CE tumor and 5 cm3 NCE tumor in line with the updated RANO criteria
Study patients are allocated to either the supramaximal or maximal safe resection group and will undergo evaluation at presentation baseline and during the follow-up period at 6 weeks 3 months and 6 months postoperatively Motor function will be evaluated using the NIHSS National Institute of Health Stroke Scale scale Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check ABC Shortened Token test Verbal fluency Picture description and Object naming Cognitive function will be assessed using the Montreal Cognitive Assessment MOCA Patient functioning with be assessed with the Karnofsky Performance Scale KPS and the ASA American Society of Anesthesiologists physical status classification system Health-related quality of life HRQoL will be assessed with the EORTC QLQ C30 EORTC QLQ BN20 and EQ 5D questionnaires Overall survival and progression-free survival will be assessed We expect to complete patient inclusion in 4 years The estimated duration of the study including follow-up will be 5 years
The primary study objective is to evaluate the safety and efficacy of supramaximal resection versus safe maximal resection in HGG patients as measured by overall survival OS and postoperative NIHSS deterioration Secondary study objectives are to evaluate extent of resection of CE and NCE tumor quality of life progression-free survival PFS onco-functional outcome OFO and SAEs after SMR or maximal safe resections as measured by volumetric analyses of contrast-enhanced MRI images with gadolinium combined with FLAIR images tumor progression on MRI scans quality of life questionnaires EORTC QLQ C30 EORTC QLQ BN20 EQ 5D combining postoperative residual volume with NIHSS outcomes and recording SAEs respectively
Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals located in Europe and the United States The study is carried out by centers from the ENCRAM Consortium
Study patients are allocated to either the supramaximal or maximal safe resection group and will undergo evaluation at presentation baseline and during the follow-up period at 6 weeks 3 months and 6 months postoperatively Motor function will be evaluated using the NIHSS National Institute of Health Stroke Scale scale Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check ABC Shortened Token test Verbal fluency Picture description and Object naming Cognitive function will be assessed using the Montreal Cognitive Assessment MOCA Patient functioning with be assessed with the Karnofsky Performance Scale KPS and the ASA American Society of Anesthesiologists physical status classification system Health-related quality of life HRQoL will be assessed with the EORTC QLQ C30 EORTC QLQ BN20 and EQ 5D questionnaires Overall survival and progression-free survival will be assessed We expect to complete patient inclusion in 4 years The estimated duration of the study including follow-up will be 5 years
The primary study objective is to evaluate the safety and efficacy of supramaximal resection versus safe maximal resection in HGG patients as measured by overall survival OS and postoperative NIHSS deterioration Secondary study objectives are to evaluate extent of resection of CE and NCE tumor quality of life progression-free survival PFS onco-functional outcome OFO and SAEs after SMR or maximal safe resections as measured by volumetric analyses of contrast-enhanced MRI images with gadolinium combined with FLAIR images tumor progression on MRI scans quality of life questionnaires EORTC QLQ C30 EORTC QLQ BN20 EQ 5D combining postoperative residual volume with NIHSS outcomes and recording SAEs respectively
Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals located in Europe and the United States The study is carried out by centers from the ENCRAM Consortium
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None