The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorJasper Gerritsen

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years and ≤90 years

Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon

Written informed consent

Disqualifiers

Tumors of the cerebellum, brainstem or midline

Multifocal contrast enhancing lesions

Medical reasons precluding MRI (e.g. pacemaker)

Inability to give written informed consent

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Supramaximal resection

    Procedure/Surgery

    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.

  • Maximal safe resection

    Procedure/Surgery

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

Treatment groups

784 Participants
are divided into 2 treatment groups
Group A: Supramaximal resection1 intervention
Group B: Maximal safe resection1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Time from diagnosis to death from any cause

Time frame
Up to 5 years postoperatively
2

Neurological morbidity at 6 weeks

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

Time frame
6 weeks postoperatively

Secondary outcomes

1

Neurological morbidity at 3 months

NIHSS deterioration of 1 point or more at 3 months after surgery

Time frame
3 months postoperatively
2

Neurological morbidity at 6 months

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

Time frame
6 months postoperatively
3

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

Time frame
Up to 5 years postoperatively
4

Residual tumor volume

Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software)

Time frame
Within 72 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jasper Gerritsen

Lead sponsor

Erasmus Medical Center

Sponsor institution

Haaglanden Medical Centre

Collaborator

Universitaire Ziekenhuizen KU Leuven

Collaborator

University Hospital Heidelberg

Collaborator

Technical University of Munich

Collaborator

Insel Gruppe AG, University Hospital Bern

Collaborator

Massachusetts General Hospital

Collaborator

University of California, San Francisco

Collaborator