NCT06118723

Brief Summary

A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively. The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).

Trial Health

83
On Track

Trial Health Score

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

Enrollment
784

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2022

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 Progress72%
Jan 2022Jan 2028

Study Start

First participant enrolled

January 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

5 years

First QC Date

October 12, 2023

Last Update Submit

February 20, 2024

Conditions

GlioblastomaHigh-grade GliomaGlioblastoma, IDH-wildtypeGlioblastoma, IDH-mutantGlioblastoma Multiforme, AdultAstrocytoma, Grade IVAstrocytoma, Grade IIIAstrocytoma, MalignantBrain NeoplasmsBrain Neoplasm, PrimaryBrain Neoplasms, AdultBrain Neoplasm, Malignant

Keywords

GlioblastomaSupramaximal resectionFLAIRectomyNon-contrast enhancementNeurological morbidityQuality of lifeOverall survivalProgression-free survival

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Time from diagnosis to death from any cause

    Up to 5 years postoperatively

  • Neurological morbidity at 6 weeks

    NIHSS deterioration of 1 point or more at 6 weeks after surgery

    6 weeks postoperatively

Secondary Outcomes (15)

  • Neurological morbidity at 3 months

    3 months postoperatively

  • Neurological morbidity at 6 months

    6 months postoperatively

  • Progression-free survival

    Up to 5 years postoperatively

  • Residual tumor volume

    Within 72 hours postoperatively

  • Onco-functional outcome

    6 weeks postoperatively

  • +10 more secondary outcomes

Study Arms (2)

Supramaximal resection

Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)

Procedure: Supramaximal resection

Maximal safe resection

Maximal safe resection of the contrast-enhancing part of the tumor

Procedure: Maximal safe resection

Interventions

Supramaximal resectionPROCEDURE

Supramaximal resection. Tumor resection continues until either the FLAIR abnormalities have been resected based on the neuronavigation (after updating the navigation intraoperatively), or when subcortical tracts are identified with intraoperative stimulation.

Also known as: Supramarginal resection, FLAIRectomy, Resection of the non-contrast-enhancing tumor
Supramaximal resection
Maximal safe resectionPROCEDURE

Maximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion.

Maximal safe resection

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
  • Multifocal contrast enhancing lesions
  • 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 (UCSF)

San Francisco, California, 94143, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Technical University Munich

Munich, Bavaria, 74076, Germany

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Haaglanden Medical Centre

The Hague, South Holland, 2512 VA, Netherlands

RECRUITING

Inselspital Universitätsspital Bern

Bern, 3010, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

GlioblastomaGliomaAstrocytomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

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
Dr.

Study Record Dates

First Submitted

October 12, 2023

First Posted

November 7, 2023

Study Start

January 1, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations

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