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

Part of paid clinical trials in San Francisco, California.

Sponsor
Jasper Gerritsen
Study ID
NCT06118723
Status
Recruiting
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Conditions

  • Astrocytoma, Grade III
  • Astrocytoma, Grade IV
  • Astrocytoma, Malignant
  • Brain Neoplasm, Malignant
  • Brain Neoplasm, Primary
  • Brain Neoplasms
  • Brain Neoplasms, Adult
  • Glioblastoma
  • Glioblastoma Multiforme, Adult
  • Glioblastoma, IDH-mutant
  • Glioblastoma, IDH-wildtype
  • High-grade Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Jan 1, 2022
Status verified
Feb 2024
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
784 participants (estimated)

Arms

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

Primary Outcome Measure

Overall survival [ Time Frame: Up to 5 years postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF)San FranciscoCalifornia94143
Mitchel Berger, MD
Massachusetts General HospitalBostonMassachusetts02114
Brian Nahed, MD

Find similar trials in San Francisco, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, San Francisco (UCSF)· San Francisco, CAMassachusetts General Hospital· Boston, MA

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