Trial Title:
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
NCT ID:
NCT06118723
Condition:
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
Conditions: Official terms:
Neoplasms
Glioblastoma
Glioma
Astrocytoma
Brain Neoplasms
Conditions: Keywords:
Glioblastoma
Supramaximal resection
FLAIRectomy
Non-contrast enhancement
Neurological morbidity
Quality of life
Overall survival
Progression-free survival
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Supramaximal resection
Description:
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.
Arm group label:
Supramaximal resection
Other name:
Supramarginal resection
Other name:
FLAIRectomy
Other name:
Resection of the non-contrast-enhancing tumor
Intervention type:
Procedure
Intervention name:
Maximal safe resection
Description:
Maximal safe resection. Tumor resection continues until maximal safe resection has been
achieved as by the neurosurgeon's opinion.
Arm group label:
Maximal safe resection
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).
Detailed description:
This is an international, multicenter, prospective, observational, 2-arm cohort study
(registration: clinicaltrials.gov ID number TBA). Eligible patients are operated with
supramaximal resection versus maximal resection with a 1:3 ratio with a sequential
computer-generated random number as subject ID. Intraoperative mapping techniques and/or
surgical adjuncts can be used in both treatment arms to ensure the safety of the
resection (to minimize the risk of postoperative deficits). Supramaximal resection is
defined as 0 cm3 CE tumor and 5 cm3 or less NCE tumor, whereas maximal resection is
defined as 0 cm3 CE tumor and >5 cm3 NCE tumor (in line with the updated RANO criteria).
Study patients are allocated to either the supramaximal or maximal safe resection group
and will undergo evaluation at presentation (baseline) and during the follow-up period at
6 weeks, 3 months, and 6 months postoperatively. Motor function will be evaluated using
the NIHSS (National Institute of Health Stroke Scale) scale. Language function will be
evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside
Check (ABC), Shortened Token test, Verbal fluency, Picture description and Object naming.
Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA).
Patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the
ASA (American Society of Anesthesiologists) physical status classification system.
Health-related quality of life (HRQoL) will be assessed with the EORTC QLQ C30, EORTC QLQ
BN20 and EQ 5D questionnaires. Overall survival and progression-free survival will be
assessed. We expect to complete patient inclusion in 4 years. The estimated duration of
the study (including follow-up) will be 5 years.
The primary study objective is to evaluate the safety and efficacy of supramaximal
resection versus safe maximal resection in HGG patients as measured by overall survival
(OS) and postoperative NIHSS deterioration. Secondary study objectives are to evaluate
extent of resection of CE and NCE tumor, quality of life, progression-free survival
(PFS), onco-functional outcome (OFO), and SAEs after SMR or maximal safe resections as
measured by volumetric analyses of contrast-enhanced MRI images with gadolinium combined
with FLAIR images, tumor progression on MRI scans, quality of life questionnaires (EORTC
QLQ C30, EORTC QLQ BN20, EQ 5D), combining postoperative residual volume with NIHSS
outcomes, and recording SAEs respectively.
Patients will be recruited from the neurosurgical or neurological outpatient clinic or
through referral from general hospitals of the participating neurosurgical hospitals,
located in Europe and the United States. The study is carried out by centers from the
ENCRAM Consortium.
Criteria for eligibility:
Study pop:
Patients with primary high-grade glioma will be recruited from the neurosurgical or
neurological outpatient clinic or through referral from general hospitals of the
participating neurosurgical hospitals, located in Europe and the United States. The study
is carried out by centers from the ENCRAM Consortium.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
University of California, San Francisco (UCSF)
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mitchel Berger, MD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Nahed, MD
Facility:
Name:
University Hospitals Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Steven De Vleeschouwer, MD PhD
Facility:
Name:
Universitätsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christine Jungk, MD PhD
Contact backup:
Last name:
Sandro Krieg, MD MBA
Facility:
Name:
Technical University Munich
Address:
City:
Munich
Zip:
74076
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Arthur Wagner, MD PhD
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jasper Gerritsen, MD PhD
Facility:
Name:
Haaglanden Medical Centre
Address:
City:
The Hague
Zip:
2512 VA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marike Broekman, MD PhD
Facility:
Name:
Inselspital Universitätsspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Philippe Schucht, MD PhD
Start date:
January 1, 2022
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Jasper Gerritsen
Agency class:
Other
Collaborator:
Agency:
Haaglanden Medical Centre
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Hospital Heidelberg
Agency class:
Other
Collaborator:
Agency:
Technical University of Munich
Agency class:
Other
Collaborator:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06118723
