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

Glioblastoma Clinical Trial

— RESBIOP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06146725
• Other study ID #: MEC-2020-0812-3
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2029

Study information

• Verified date: November 2023
• Source: Erasmus Medical Center
• Contact: Jasper Gerritsen, MD PhD
• Phone: +31107036130
• Email: j.gerritsen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 564
• Est. completion date: January 1, 2029
• Est. primary completion date: January 1, 2028
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Glioblastoma Multiforme of Brain
• Glioblastoma Multiforme, Adult
• Glioblastoma, IDH-wildtype

Intervention

Procedure:
• Tumor resection
Maximal safe resection of the tumor
• Tumor biopsy
Biopsy of the tumor

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven
Germany	University Hospital Heidelberg	Heidelberg
Germany	Technical University Munich	Munich	Bavaria
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland
Netherlands	Haaglanden Medical Center	The Hague
Switzerland	Inselspital Universitätsspital Bern	Bern
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of California, San Francisco	San Francisco	California

Sponsors (8)

Lead Sponsor	Collaborator
Jasper Gerritsen	Haaglanden Medical Centre, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, Technical University of Munich, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, University of California, San Francisco

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Time from diagnosis to death from any cause	Up to 5 years postoperatively
Primary	Adjuvant treatment with chemotherapy and radiotherapy	Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery	6 months postoperatively
Secondary	Progression-free survival	Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first	Up to 5 years postoperatively
Secondary	Neurological morbidity at 6 weeks	NIHSS deterioration of 1 point or more at 6 weeks after surgery	6 weeks postoperatively
Secondary	Neurological morbidity at 3 months	NIHSS deterioration of 1 point or more at 3 months after surgery	3 months postoperatively
Secondary	Neurological morbidity at 6 months	NIHSS deterioration of 1 point or more at 6 months after surgery	6 months postoperatively
Secondary	Quality of life at 6 weeks (EORTC QLQ C30)	Quality of life as assessed by the EORTC QLQ C30 questionnaire	6 weeks postoperatively
Secondary	Quality of life at 3 months (EORTC QLQ C30)	Quality of life as assessed by the EORTC QLQ C30 questionnaire	3 months postoperatively
Secondary	Quality of life at 6 months (EORTC QLQ C30)	Quality of life as assessed by the EORTC QLQ C30 questionnaire	6 months postoperatively
Secondary	Quality of life at 6 weeks (EORTC QLQ BN20)	Quality of life as assessed by the EORTC QLQ BN20 questionnaire	6 weeks postoperatively
Secondary	Quality of life at 3 months (EORTC QLQ BN20)	Quality of life as assessed by the EORTC QLQ BN20 questionnaire	3 months postoperatively
Secondary	Quality of life at 6 months (EORTC QLQ BN20)	Quality of life as assessed by the EORTC QLQ BN20 questionnaire	6 months postoperatively
Secondary	Quality of life at 6 weeks (EQ-5D)	Quality of life as assessed by the EQ-5D questionnaire	6 weeks postoperatively
Secondary	Quality of life at 3 months (EQ-5D)	Quality of life as assessed by the EQ-5D questionnaire	3 months postoperatively
Secondary	Quality of life at 6 months (EQ-5D)	Quality of life as assessed by the EQ-5D questionnaire	6 months postoperatively
Secondary	Serious Adverse Events	Serious Adverse Events within 6 weeks postoperatively	6 weeks postoperatively