NCT06146725

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 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.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
564

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
5 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jan 2023Jan 2029

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

November 18, 2023

Last Update Submit

November 18, 2023

Conditions

GlioblastomaGlioblastoma, IDH-wildtypeGlioblastoma MultiformeGlioblastoma Multiforme, AdultGlioblastoma Multiforme of Brain

Keywords

ResectionBiopsySurvivalQuality of life

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Time from diagnosis to death from any cause

    Up to 5 years postoperatively

  • Adjuvant treatment with chemotherapy and radiotherapy

    Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery

    6 months postoperatively

Secondary Outcomes (14)

  • Progression-free survival

    Up to 5 years postoperatively

  • Neurological morbidity at 6 weeks

    6 weeks postoperatively

  • Neurological morbidity at 3 months

    3 months postoperatively

  • Neurological morbidity at 6 months

    6 months postoperatively

  • Quality of life at 6 weeks (EORTC QLQ C30)

    6 weeks postoperatively

  • +9 more secondary outcomes

Study Arms (2)

Tumor resection

Tumor resection

Procedure: Tumor resection

Tumor biopsy

Tumor biopsy

Procedure: Tumor biopsy

Interventions

Tumor resectionPROCEDURE

Maximal safe resection of the tumor

Tumor resection
Tumor biopsyPROCEDURE

Biopsy of the tumor

Tumor biopsy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • Age ≥18 years and ≤90 years
  • Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
  • Written informed consent

You may not qualify if:

  • Tumors of the cerebellum, brainstem or midline
  • Medical reasons precluding MRI (e.g. pacemaker)
  • Inability to give written informed consent
  • Secondary high-grade glioma due to malignant transformation from low-grade glioma
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University Hospital Leuven

Leuven, Belgium

RECRUITING

Technical University Munich

Munich, Bavaria, 74076, Germany

NOT YET RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Haaglanden Medical Center

The Hague, Netherlands

RECRUITING

Inselspital Universitätsspital Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

Related Publications (1)

  • Gerritsen JKW, Young JS, Krieg SM, Jungk C, Ille S, Schucht P, Nahed BV, Broekman MLD, Berger M, De Vleeschouwer S, Vincent AJPE. Resection versus biopsy in patients with glioblastoma (RESBIOP study): study protocol for an international multicentre prospective cohort study (ENCRAM 2202). BMJ Open. 2024 Sep 10;14(9):e081689. doi: 10.1136/bmjopen-2023-081689.

    PMID: 39260848DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Transurethral Resection of Bladder

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jasper Gerritsen, MD PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Gerritsen, MD PhD

CONTACT

+31107036130j.gerritsen@erasmusmc.nl

Arnaud Vincent, MD PhD

CONTACT

+31107034211a.vincent@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Jasper K.W. Gerritsen MD PhD

Study Record Dates

First Submitted

November 18, 2023

First Posted

November 27, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

November 27, 2023

Record last verified: 2023-11

Locations

BE(1)US(2)DE(2)CH(1)NL(2)