Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283927
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-21
Brief Title:
The RECSUR-study Resection Versus Best Oncological Treatment for Recurrent Glioblastoma ENCRAM 2302
Sponsor:
Jasper Gerritsen
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The RECSUR-study Resection Versus Best Oncological Treatment for Recurrent Glioblastoma Study Protocol for An International Multicenter Prospective Cohort Study ENCRAM 2302
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:
RECSUR
Brief Summary:
Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival However the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined The aim of this study therefore is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups
This study is an international multicenter prospective observational cohort study Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 11 ratio as decided by the tumor board Primary endpoints are 1 proportion of patients with NIHSS National Institute of Health Stroke Scale deterioration at 6 weeks after surgery and 2 overall survival Secondary endpoints are 1 progression-free survival PFS 2 NIHSS deterioration at 3 months and 6 months after surgery 3 health-related quality of life HRQoL at 6 weeks 3 months and 6 months after surgery and 4 frequency and severity of Serious Adverse Events SAEs in each arm Estimated total duration of the study is 5 years Patient inclusion is 4 years follow-up is 1 year
The study has been approved by the Medical Ethics Committee METC Zuid-West HollandErasmus Medical Center MEC-2020-0812 The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media
This study is an international multicenter prospective observational cohort study Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 11 ratio as decided by the tumor board Primary endpoints are 1 proportion of patients with NIHSS National Institute of Health Stroke Scale deterioration at 6 weeks after surgery and 2 overall survival Secondary endpoints are 1 progression-free survival PFS 2 NIHSS deterioration at 3 months and 6 months after surgery 3 health-related quality of life HRQoL at 6 weeks 3 months and 6 months after surgery and 4 frequency and severity of Serious Adverse Events SAEs in each arm Estimated total duration of the study is 5 years Patient inclusion is 4 years follow-up is 1 year
The study has been approved by the Medical Ethics Committee METC Zuid-West HollandErasmus Medical Center MEC-2020-0812 The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media
Detailed Description:
This is an international multicenter prospective cohort study Eligible patients are operated or receive best oncological treatment with a 11 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
Study patients undergo tumor re-resection or receive best oncological treatment 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 and MRC Medical Research Council 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 This neurolinguistic test-battery is the result of a consensus between the participating centers Cognitive function will be assessed using the Montreal Cognitive Assessment MOCA Overall patient functioning with be assessed with the Karnofsky Performance Scale KPS and the ASA American Society of Anesthesiologists physical status classification system for comorbidities Health-related quality of life HRQoL will be assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20 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 re-resection versus best oncological treatment neurological morbidity and overall survival in recurrent glioblastoma patients as expressed by NIHSS scores and survival data Secondary study objectives are to study the overall progressive-free survival PFS long-term neurological morbidity 3 months and 6 months postoperatively health-related quality of life HRQoL and Serious Adverse Events SAEs after resection versus best oncological treatment as expressed by progression on follow up MRI scans based on the RANO criteria24 for tumor progression NIHSS scores quality of life questionnaires EORTC QLQ C30 EORTC QLQ BN20 EQ-5D and registration of SAEs
Patients will be recruited for the study from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals of the ENCRAM Research Consortium located in Europe and the United States
Study patients undergo tumor re-resection or receive best oncological treatment 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 and MRC Medical Research Council 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 This neurolinguistic test-battery is the result of a consensus between the participating centers Cognitive function will be assessed using the Montreal Cognitive Assessment MOCA Overall patient functioning with be assessed with the Karnofsky Performance Scale KPS and the ASA American Society of Anesthesiologists physical status classification system for comorbidities Health-related quality of life HRQoL will be assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20 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 re-resection versus best oncological treatment neurological morbidity and overall survival in recurrent glioblastoma patients as expressed by NIHSS scores and survival data Secondary study objectives are to study the overall progressive-free survival PFS long-term neurological morbidity 3 months and 6 months postoperatively health-related quality of life HRQoL and Serious Adverse Events SAEs after resection versus best oncological treatment as expressed by progression on follow up MRI scans based on the RANO criteria24 for tumor progression NIHSS scores quality of life questionnaires EORTC QLQ C30 EORTC QLQ BN20 EQ-5D and registration of SAEs
Patients will be recruited for the study from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals of the ENCRAM Research Consortium located in Europe and the United States
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