The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
NCT ID: NCT06283927
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
464 participants
OBSERVATIONAL
2023-01-01
2028-01-01
Brief Summary
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This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.
The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Re-resection
Resection of the recurrent tumor
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
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
Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)
Best supportive care
Best supportive care, focused on alleviating symptoms
Interventions
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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
Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)
Best supportive care
Best supportive care, focused on alleviating symptoms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
90 Years
ALL
No
Sponsors
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Haaglanden Medical Centre
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
University Hospital Heidelberg
OTHER
Technical University of Munich
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Massachusetts General Hospital
OTHER
University of California, San Francisco
OTHER
Jasper Gerritsen
OTHER
Responsible Party
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Jasper Gerritsen
Dr.
Principal Investigators
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Jasper Gerritsen, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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University of California, San Francisco
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University Hospital Leuven
Leuven, , Belgium
University Hospital Heidelberg
Heidelberg, , Germany
Technical University Munich
Munich, , Germany
Erasmus MC
Rotterdam, South Holland, Netherlands
Medical Center Haaglanden
The Hague, South Holland, Netherlands
Inselspital Universitätsspital Bern
Bern, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Mitchel Berger, MD PhD
Role: primary
Brian Nahed, MD PhD
Role: primary
Steven De Vleeschouwer, MD PhD
Role: primary
Christine Jungk, Dr. med.
Role: primary
Arthur Wagner, MD
Role: primary
Philippe Schucht, MD PhD
Role: primary
Other Identifiers
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MEC-2020-0812-5
Identifier Type: -
Identifier Source: org_study_id
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