The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
Recruiting now
Conditions studied: 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
In brief
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 facts
- Study ID
- NCT06118723
- Run by
- Jasper Gerritsen
- People needed
- 784
- Starts
- 2022-01-01
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2024-02-22
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
You may not qualify if…
- 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
Where it is running
- Haaglanden Medical Centre — The Hague, South Holland, Netherlands (enrolling)
- University of California, San Francisco (UCSF) — San Francisco, California, United States (enrolling)
- University Hospitals Leuven — Leuven, Belgium (enrolling)
- Universitätsklinikum Heidelberg — Heidelberg, Baden-Wurttemberg, Germany (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Erasmus Medical Center — Rotterdam, South Holland, Netherlands (enrolling)
- Inselspital Universitätsspital Bern — Bern, Switzerland
- Technical University Munich — Munich, Bavaria, Germany
Full record on ClinicalTrials.gov
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