Recruiting

Supramaximal Resection vs. Maximal Resection

Sponsor:

Jasper Gerritsen

Code:

NCT06118723

Conditions

Glioblastoma

High-grade Glioma

Glioblastoma, IDH-wildtype

Glioblastoma, IDH-mutant

Glioblastoma Multiforme, Adult

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Supramaximal resection

Maximal safe resection

Study Details

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).

Conditions

Glioblastoma

High-grade Glioma

Glioblastoma, IDH-wildtype

Glioblastoma, IDH-mutant

Glioblastoma Multiforme, Adult

Study ID

NCT06118723

Start date

Jan 1, 2022

Status verified date

Feb, 2024

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Tumors of the cerebellum, brainstem or midline
2. Multifocal contrast enhancing lesions
3. Medical reasons precluding MRI (e.g. pacemaker)
4. Inability to give written informed consent
5. Secondary high-grade glioma due to malignant transformation from low-grade glioma
6. 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

Study Design

Enrollment

784 participants

Anticipated

Interventions and Outcome Measures

Arms

Supramaximal resection

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

Maximal safe resection

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

Interventions

Supramaximal 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.

Maximal safe resection

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

Primary outcome measure

  • Overall survival [ Time Frame: Up to 5 years postoperatively ]
  • Neurological morbidity at 6 weeks [ Time Frame: 6 weeks postoperatively ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco (UCSF)

Recruiting

San Francisco, California, United States, 94143

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Jasper Gerritsen

Last update posted

Feb 22, 2024

Last verified

Feb, 2024

Keywords

  • Glioblastoma
  • Supramaximal resection
  • FLAIRectomy
  • Non-contrast enhancement
  • Neurological morbidity
  • Quality of life
  • Overall survival
  • Progression-free survival

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jasper Gerritsen on 2024-02-22.