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JOURNAL ONKOLOGIE – STUDIE
RECSUR

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)

Rekrutierend

NCT-Nummer:
NCT06283927

Studienbeginn:
Januar 2023

Letztes Update:
28.02.2024

Wirkstoff:
Temozolomide, Lomustine

Indikation (Clinical Trials):
Glioblastoma, Astrocytoma, Recurrence

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)

Erasmus MC
3015 CE Rotterdam
NetherlandsRekrutierend» Google-Maps
Ansprechpartner:
Arnaud Vincent, MD PhD
Phone: +31639428949
E-Mail: a.vincent@erasmusmc.nl

Jasper Gerritsen, MD
Phone: +31629119553
E-Mail: j.gerritsen@erasmusmc.nl» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

This is an international, multicenter, prospective, cohort study. Eligible patients are

operated or receive best oncological treatment with a 1:1 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).

Study patients undergo tumor re-resection or receive best oncological treatment 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) and MRC (Medical Research Council) 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. This neurolinguistic test-battery is the result of a consensus between the

participating centers. Cognitive function will be assessed using the Montreal Cognitive

Assessment (MOCA). Overall patient functioning with be assessed with the Karnofsky

Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status

classification system for comorbidities. Health-related quality of life (HRQoL) will be

assessed with the EQ-5D questionnaire and the EORTC QLQ-C30 and EORTC QLQ-BN20

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 re-resection versus

best oncological treatment (neurological morbidity and overall survival) in recurrent

glioblastoma patients as expressed by NIHSS scores and survival data. Secondary study

objectives are to study the overall progressive-free survival (PFS), long-term neurological

morbidity (3 months and 6 months postoperatively), health-related quality of life (HRQoL),

and Serious Adverse Events (SAEs) after resection versus best oncological treatment as

expressed by progression on follow up MRI scans based on the RANO criteria24 for tumor

progression; NIHSS scores, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20,

EQ-5D), and registration of SAEs.

Patients will be recruited for the study from the neurosurgical or neurological outpatient

clinic or through referral from general hospitals of the participating neurosurgical

hospitals of the ENCRAM Research Consortium, located in Europe and the United States.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Age ≥18 years and ≤90 years

2. Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma

based on the WHO 2021 classification for glioma

3. The tumor is suitable for resection (according to neurosurgeon)

4. 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. Clinical data unavailable for the newly diagnosed setting

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. 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

  • Re-resection
    Resection of the recurrent tumor
  • Best oncological treatment
    Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care

Geprüfte Regime

  • Re-resection:
    Resection of the recurrent tumor
  • Temozolomide:
    Re-challenge Temozolomide chemotherapy
  • Lomustine:
    Second line chemotherapy with Lomustine
  • Re-irradiation:
    Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor
  • Experimental therapy (Immunotherapy / Oncolytic virotherapy / ):
    Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)
  • Best supportive care:
    Best supportive care, focused on alleviating symptoms

Quelle: ClinicalTrials.gov


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