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JOURNAL ONKOLOGIE – STUDIE
SUPRAMAX

The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

Rekrutierend

NCT-Nummer:
NCT06118723

Studienbeginn:
Januar 2022

Letztes Update:
22.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms, Glioblastoma, Glioma, Astrocytoma, Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Jasper Gerritsen

Collaborator:
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,

Studienleiter

Jasper Gerritsen, MD PhD
Principal Investigator
Erasmus Medical Center

Kontakt

Studienlocations
(3 von 8)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - Up to 5 years postoperatively):
Time from diagnosis to death from any cause

2. Neurological morbidity at 6 weeks (Time Frame - 6 weeks postoperatively):
NIHSS deterioration of 1 point or more at 6 weeks after surgery

Secondary outcome:

1. Neurological morbidity at 3 months (Time Frame - 3 months postoperatively):
NIHSS deterioration of 1 point or more at 3 months after surgery

2. Neurological morbidity at 6 months (Time Frame - 6 months postoperatively):
NIHSS deterioration of 1 point or more at 6 months after surgery

3. Progression-free survival (Time Frame - Up to 5 years postoperatively):
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

4. Residual tumor volume (Time Frame - Within 72 hours postoperatively):
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)

5. Onco-functional outcome (Time Frame - 6 weeks postoperatively):
According to the OFO classification, consisting of the combination of presence/absence of functional deterioration with gross-total resection

6. Quality of life at 6 weeks (EORTC QLQ C30) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

7. Quality of life at 6 weeks (EORTC QLQ BN20) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

8. Quality of life at 6 weeks (EQ-5D) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

9. Quality of life at 3 months (EORTC QLQ C30) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

10. Quality of life at 3 months (EORTC QLQ BN20) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

11. Quality of life at 3 months (EQ-5D) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

12. Quality of life at 6 months (EORTC QLQ C30) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

13. Quality of life at 6 months (EORTC QLQ BN20) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

14. Quality of life at 6 months (EQ-5D) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

15. Serious Adverse Events (Time Frame - 6 weeks postoperatively):
Serious Adverse Events within 6 weeks postoperatively

Studien-Arme

  • Supramaximal resection
    Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)
  • Maximal safe resection
    Maximal safe resection of the contrast-enhancing part of the tumor

Geprüfte Regime

  • Supramaximal resection (Supramarginal resection / FLAIRectomy / Resection of the non-contrast-enhancing tumor / ):
    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.
  • Maximal safe resection:
    Maximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion.

Quelle: ClinicalTrials.gov


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