NCT06118723 The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
| NCT ID | NCT06118723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jasper Gerritsen |
| Condition | Glioblastoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 784 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 784 participants in total. It began in 2022-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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
Contact & Investigator
Jasper Gerritsen, MD PhD
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06118723 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06118723 currently recruiting?
Yes, NCT06118723 is actively recruiting participants. Contact the research team at j.gerritsen@erasmusmc.nl for enrollment information.
Where is the NCT06118723 trial being conducted?
This trial is being conducted at San Francisco, United States, Boston, United States, Leuven, Belgium, Heidelberg, Germany and 4 additional locations.
Who is sponsoring the NCT06118723 clinical trial?
NCT06118723 is sponsored by Jasper Gerritsen. The principal investigator is Jasper Gerritsen, MD PhD at Erasmus Medical Center. The trial plans to enroll 784 participants.
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