NCT06118723Recruiting
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
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).
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Countries
- Switzerland, Germany, United States, Belgium, Netherlands
- Sponsor
- Jasper Gerritsen(Other)
- Protocol no.
- MEC-2020-0812-2
- Conditions
- Glioblastoma, High-grade Glioma, Glioblastoma, IDH-wildtype, Glioblastoma, IDH-mutant, Glioblastoma Multiforme, Adult, Astrocytoma, Grade IV, Astrocytoma, Grade III, Astrocytoma, Malignant, Brain Neoplasms, Brain Neoplasm, Primary, Brain Neoplasms, Adult, Brain Neoplasm, Malignant
- Interventions
- Procedure
Treatments studied
- Supramaximal resection
- Maximal safe resection
Collaborators
Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco
Locations · 6
- Heidelberg, GermanyUniversitätsklinikum HeidelbergRecruiting at this site
- San Francisco, United StatesUniversity of California, San Francisco (UCSF)Recruiting at this site
- Boston, United StatesMassachusetts General HospitalRecruiting at this site
- Leuven, BelgiumUniversity Hospitals LeuvenRecruiting at this site
- Rotterdam, NetherlandsErasmus Medical CenterRecruiting at this site
- The Hague, NetherlandsHaaglanden Medical CentreRecruiting at this site
In total, worldwide, 6 of the 8 sites listed in the registry are recruiting; the other 2 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: February 22, 2024).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.