RecruitingNCT06118723

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

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


Sponsor

Jasper Gerritsen

Enrollment

784 participants

Start Date

Jan 1, 2022

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

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

Exclusion Criteria6

  • 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

Interventions

PROCEDURESupramaximal resection

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.

PROCEDUREMaximal safe resection

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


Locations(8)

University of California, San Francisco (UCSF)

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University Hospitals Leuven

Leuven, Belgium

Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Technical University Munich

Munich, Bavaria, Germany

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Haaglanden Medical Centre

The Hague, South Holland, Netherlands

Inselspital Universitätsspital Bern

Bern, Switzerland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06118723


Related Trials