Trial Title:
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
NCT ID:
NCT06146725
Condition:
Glioblastoma
Glioblastoma, IDH-wildtype
Glioblastoma Multiforme
Glioblastoma Multiforme, Adult
Glioblastoma Multiforme of Brain
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
Resection
Biopsy
Survival
Quality of life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor resection
Description:
Maximal safe resection of the tumor
Arm group label:
Tumor resection
Intervention type:
Procedure
Intervention name:
Tumor biopsy
Description:
Biopsy of the tumor
Arm group label:
Tumor biopsy
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 3:1 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: clinicaltrials.gov ID number TBA). Eligible patients are
treated with either resection or biopsy with a 3:1 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.
Criteria for eligibility:
Study pop:
Patients with primary high-grade glioma 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.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age ≥18 years and ≤90 years
2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
3. Written informed consent
Exclusion Criteria:
1. Tumors of the cerebellum, brainstem or midline
2. Medical reasons precluding MRI (e.g. pacemaker)
3. Inability to give written informed consent
4. Secondary high-grade glioma due to malignant transformation from low-grade glioma
5. Second primary malignancy within the past 5 years with the exception of adequately
treated in situ carcinoma of any organ or basal cell carcinoma of the skin
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mitchel Berger, MD PhD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Nahed, MD
Facility:
Name:
University Hospital Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Steven De Vleeschouwer, MD PhD
Facility:
Name:
Technical University Munich
Address:
City:
Munich
Zip:
74076
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Arthur Wagner, MD PhD
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christine Jungk, Dr. med.
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jasper Gerritsen, MD PhD
Facility:
Name:
Haaglanden Medical Center
Address:
City:
The Hague
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marike Broekman, MD PhD
Facility:
Name:
Inselspital Universitätsspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Philippe Schucht, MD PhD
Start date:
January 1, 2023
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Jasper Gerritsen
Agency class:
Other
Collaborator:
Agency:
Haaglanden Medical Centre
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Hospital Heidelberg
Agency class:
Other
Collaborator:
Agency:
Technical University of Munich
Agency class:
Other
Collaborator:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146725
