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The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06146725
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Jasper Gerritsen
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jasper Gerritsen, MD PhD
Principal Investigator Affiliation	Erasmus Medical Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium, Germany, Netherlands, Switzerland, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Glioblastoma Multiforme, Adult, Glioblastoma Multiforme of Brain

Additional Details

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.

Arms & Interventions

Arms

: Tumor resection

Tumor resection

: Tumor biopsy

Tumor biopsy

Interventions

Procedure: - Tumor resection

Maximal safe resection of the tumor

Procedure: - Tumor biopsy

Biopsy of the tumor

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California, San Francisco, San Francisco, California

Status

Recruiting

Address

University of California, San Francisco

San Francisco, California, 94143

Site Contact

Mitchel Berger, MD PhD

j.gerritsen@erasmusmc.nl

+31107036130

Massachusetts General Hospital, Boston, Massachusetts

Status