Glioblastoma Clinical Trial
— SUPRAMAXOfficial title:
The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
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).
Status | Recruiting |
Enrollment | 784 |
Est. completion date | January 1, 2028 |
Est. primary completion date | January 1, 2027 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospitals Leuven | Leuven | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | Baden-Württemberg |
Germany | Technical University Munich | Munich | Bavaria |
Netherlands | Erasmus Medical Center | Rotterdam | Zuid-Holland |
Netherlands | Haaglanden Medical Centre | The Hague | Zuid-Holland |
Switzerland | Inselspital Universitätsspital Bern | Bern | |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of California, San Francisco (UCSF) | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Jasper Gerritsen | Haaglanden Medical Centre, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, Technical University of Munich, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, University of California, San Francisco |
United States, Belgium, Germany, Netherlands, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | Time from diagnosis to death from any cause | Up to 5 years postoperatively | |
Primary | Neurological morbidity at 6 weeks | NIHSS deterioration of 1 point or more at 6 weeks after surgery | 6 weeks postoperatively | |
Secondary | Neurological morbidity at 3 months | NIHSS deterioration of 1 point or more at 3 months after surgery | 3 months postoperatively | |
Secondary | Neurological morbidity at 6 months | NIHSS deterioration of 1 point or more at 6 months after surgery | 6 months postoperatively | |
Secondary | Progression-free survival | Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first | Up to 5 years postoperatively | |
Secondary | Residual tumor volume | Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software) | Within 72 hours postoperatively | |
Secondary | Onco-functional outcome | According to the OFO classification, consisting of the combination of presence/absence of functional deterioration with gross-total resection | 6 weeks postoperatively | |
Secondary | Quality of life at 6 weeks (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 6 weeks (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 6 weeks (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 6 weeks postoperatively | |
Secondary | Quality of life at 3 months (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 3 months postoperatively | |
Secondary | Quality of life at 3 months (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 3 months postoperatively | |
Secondary | Quality of life at 3 months (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 3 months postoperatively | |
Secondary | Quality of life at 6 months (EORTC QLQ C30) | Quality of life as assessed by the EORTC QLQ C30 questionnaire | 6 months postoperatively | |
Secondary | Quality of life at 6 months (EORTC QLQ BN20) | Quality of life as assessed by the EORTC QLQ BN20 questionnaire | 6 months postoperatively | |
Secondary | Quality of life at 6 months (EQ-5D) | Quality of life as assessed by the EQ-5D questionnaire | 6 months postoperatively | |
Secondary | Serious Adverse Events | Serious Adverse Events within 6 weeks postoperatively | 6 weeks postoperatively |
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