Trial Title:
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
NCT ID:
NCT06283927
Condition:
Glioblastoma
Glioblastoma Multiforme
Glioblastoma, IDH-wildtype
Glioblastoma Multiforme of Brain
Glioblastoma Multiforme, Adult
Recurrent Glioblastoma
Astrocytoma, Malignant
Astrocytoma of Brain
Conditions: Official terms:
Glioblastoma
Astrocytoma
Recurrence
Temozolomide
Lomustine
Conditions: Keywords:
Glioblastoma
Radiotherapy
Chemotherapy
Re-resection
Resection
Overall survival
Progression-free survival
Neurological morbidity
Safety
Serious Adverse Events
Quality of life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Re-resection
Description:
Resection of the recurrent tumor
Arm group label:
Re-resection
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Re-challenge Temozolomide chemotherapy
Arm group label:
Best oncological treatment
Intervention type:
Drug
Intervention name:
Lomustine
Description:
Second line chemotherapy with Lomustine
Arm group label:
Best oncological treatment
Intervention type:
Radiation
Intervention name:
Re-irradiation
Description:
Re-irradiation with single dose, fractionated, or hypofractionated radiation of the
recurrent tumor
Arm group label:
Best oncological treatment
Intervention type:
Procedure
Intervention name:
Experimental therapy
Description:
Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is
not exhaustive)
Arm group label:
Best oncological treatment
Other name:
Immunotherapy
Other name:
Oncolytic virotherapy
Intervention type:
Other
Intervention name:
Best supportive care
Description:
Best supportive care, focused on alleviating symptoms
Arm group label:
Best oncological treatment
Summary:
Previous evidence has indicated that resection for recurrent glioblastoma might benefit
the prognosis of these patients in terms of overall survival. However, the demonstrated
safety profile of this approach is contradictory in the literature and the specific
benefits in distinct clinical and molecular patient subgroups remains ill-defined. The
aim of this study, therefore, is to compare the effects of resection and best oncological
treatment for recurrent glioblastoma as a whole and in clinically important subgroups.
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.
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.
Criteria for eligibility:
Study pop:
Patients with recurrent glioblastoma 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mitchel Berger, MD PhD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Nahed, MD PhD
Facility:
Name:
University Hospital Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Steven De Vleeschouwer, MD PhD
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christine Jungk, Dr. med.
Facility:
Name:
Technical University Munich
Address:
City:
Munich
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Arthur Wagner, MD
Facility:
Name:
Erasmus MC
Address:
City:
Rotterdam
Zip:
3015 CE
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Arnaud Vincent, MD PhD
Phone:
+31639428949
Email:
a.vincent@erasmusmc.nl
Contact backup:
Last name:
Jasper Gerritsen, MD
Phone:
+31629119553
Email:
j.gerritsen@erasmusmc.nl
Facility:
Name:
Medical Center Haaglanden
Address:
City:
The Hague
Zip:
2261 CP
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marike Broekman, MD PhD
Phone:
+31639758253
Email:
m.broekman@haaglandenmc.nl
Facility:
Name:
Inselspital Universitätsspital Bern
Address:
City:
Bern
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Philippe Schucht, MD PhD
Start date:
January 1, 2023
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/NCT06283927
