Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06146725
Status:
RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-11-18
Brief Title:
The RESBIOP-study Resection Versus Biopsy in High-grade Glioma Patients ENCRAM 2202
Sponsor:
Jasper Gerritsen
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The RESBIOP-study Resection Versus Biopsy in High-grade Glioma Patients ENCRAM 2202
Status:
RECRUITING
Status Verified Date:
2023-11
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:
RESBIOP
Brief Summary:
There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients 70 years or those with limited functioning performance at presentation KPS 70 Therefore the decision between resection and biopsy is varied amongst neurosurgeons internationally and at times even within an instiutition This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival functional neurological and quality of life outcomes in these patient subgroups Furthermore it evaluates which modality would maximize the potential to undergo adjuvant treatment
This study is an international multicenter prospective 2-arm cohort study of observational nature Consecutive HGG patients will be treated with resection or biopsy at a 31 ratio Primary endpoints are 1 overall survival OS and 2 proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy Secondary endpoints are 1 proportion of patients with NIHSS National Institute of Health Stroke Scale deterioration at 6 weeks 3 months and 6 months after surgery 2 progression-free survival PFS 3 quality of life at 6 weeks 3 months and 6 months after surgery and 4 frequency and severity of Serious Adverse Events SAEs Total duration of the study is 5 years Patient inclusion is 4 years follow-up is 1 year
This study is an international multicenter prospective 2-arm cohort study of observational nature Consecutive HGG patients will be treated with resection or biopsy at a 31 ratio Primary endpoints are 1 overall survival OS and 2 proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy Secondary endpoints are 1 proportion of patients with NIHSS National Institute of Health Stroke Scale deterioration at 6 weeks 3 months and 6 months after surgery 2 progression-free survival PFS 3 quality of life at 6 weeks 3 months and 6 months after surgery and 4 frequency and severity of Serious Adverse Events SAEs Total duration of the study is 5 years Patient inclusion is 4 years follow-up is 1 year
Detailed Description:
Trial design This is an international multicenter prospective observational 2-arm cohort study registration clinicaltrialsgov ID number TBA Eligible patients are treated with either resection or biopsy with a 31 ratio with a sequential computer-generated random number as subject ID
Study objectives The primary study objective is to evaluate safety and efficacy of resection versus biopsy in HGG patients as measured by overall survival OS and receipt of adjuvant treatment with chemotherapy and radiotherapy Secondary study objectives are to evaluate postoperative neurological morbidity progression-free survival PFS postoperative quality of life and SAEs after resection or biopsy as measured by NIHSS deteriration tumor progression on MRI scans quality of life questionnaires QLQ C30 EORTC QLQ BN20 EQ 5D and recording SAEs respectively
Study setting and participants 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 maximum safe resection group and will undergo evaluation at presentation baseline and during the follow-up period at 6 weeks 3 months 6 months and 12 months postoperatively Motor function will be evaluated using the NIHSS National Institute of Health Stroke Scale scale 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 at 12 months postoperatively We expect to complete patient inclusion in 4 years The estimated duration of the study including follow-up will be 5 years
Study objectives The primary study objective is to evaluate safety and efficacy of resection versus biopsy in HGG patients as measured by overall survival OS and receipt of adjuvant treatment with chemotherapy and radiotherapy Secondary study objectives are to evaluate postoperative neurological morbidity progression-free survival PFS postoperative quality of life and SAEs after resection or biopsy as measured by NIHSS deteriration tumor progression on MRI scans quality of life questionnaires QLQ C30 EORTC QLQ BN20 EQ 5D and recording SAEs respectively
Study setting and participants 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 maximum safe resection group and will undergo evaluation at presentation baseline and during the follow-up period at 6 weeks 3 months 6 months and 12 months postoperatively Motor function will be evaluated using the NIHSS National Institute of Health Stroke Scale scale 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 at 12 months postoperatively We expect to complete patient inclusion in 4 years The estimated duration of the study including follow-up will be 5 years
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