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JOURNAL ONKOLOGIE – STUDIE
RESBIOP

The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

Rekrutierend

NCT-Nummer:
NCT06146725

Studienbeginn:
Januar 2023

Letztes Update:
27.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

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:

Trial design This is an international, multicenter, prospective, observational, 2-arm cohort

study (registration: clinicaltrials.gov ID number TBA). Eligible patients are treated with

either resection or biopsy with a 3:1 ratio with a sequential computer-generated random

number as subject ID.

Study objectives The primary study objective is to evaluate safety and efficacy of resection

versus biopsy in HGG patients as measured by overall survival (OS) and receipt of adjuvant

treatment with chemotherapy and radiotherapy. Secondary study objectives are to evaluate

postoperative neurological morbidity, progression-free survival (PFS), postoperative quality

of life and SAEs after resection or biopsy as measured by NIHSS deteriration, tumor

progression on MRI scans, quality of life questionnaires (QLQ C30, EORTC QLQ BN20, EQ 5D),

and recording SAEs respectively.

Study setting and participants 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.

Study patients are allocated to either the supramaximal or maximum safe resection group and

will undergo evaluation at presentation (baseline) and during the follow-up period at 6

weeks, 3 months, 6 months and 12 months postoperatively. Motor function will be evaluated

using the NIHSS (National Institute of Health Stroke Scale) scale. 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 at 12 months postoperatively.

We expect to complete patient inclusion in 4 years. The estimated duration of the study

(including follow-up) will be 5 years.

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. Medical reasons precluding MRI (e.g. pacemaker)

3. Inability to give written informed consent

4. Secondary high-grade glioma due to malignant transformation from low-grade glioma

5. 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. Adjuvant treatment with chemotherapy and radiotherapy (Time Frame - 6 months postoperatively):
Proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy after surgery

Secondary outcome:

1. 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

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

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

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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

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

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

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

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

Studien-Arme

  • Tumor resection
    Tumor resection
  • Tumor biopsy
    Tumor biopsy

Geprüfte Regime

  • Tumor resection:
    Maximal safe resection of the tumor
  • Tumor biopsy:
    Biopsy of the tumor

Quelle: ClinicalTrials.gov


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