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

NCT06283927 | Recruiting

• 1 other identifier: MEC-2020-0812-5
• Study Type: observational
• Target: 464
• Locations: 5 countries
• Sites: 8

Brief 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.

Conditions

Glioblastoma; Glioblastoma Multiforme; Glioblastoma, IDH-wildtype; Glioblastoma Multiforme of Brain; Glioblastoma Multiforme, Adult; Recurrent Glioblastoma; Astrocytoma, Malignant; Astrocytoma of Brain

Keywords

Glioblastoma; Radiotherapy; Chemotherapy; Re-resection; Resection; Overall survival; Progression-free survival; Neurological morbidity; Safety; Serious Adverse Events; Quality of life

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Time from diagnosis to death from any cause

  Up to 5 years postoperatively

• Neurological morbidity at 6 weeks

  NIHSS deterioration of 1 point or more at 6 weeks after surgery

  6 weeks postoperatively

Secondary Outcomes (14)

• Neurological morbidity at 3 months

  3 months postoperatively

• Neurological morbidity at 6 months

  6 months postoperatively

• Progression-free survival

  Up to 5 years postoperatively

• Residual tumor volume

  Within 72 hours postoperatively

• Quality of life at 6 weeks (EORTC QLQ C30)

  6 weeks postoperatively

Study Arms (2)

Re-resection

Resection of the recurrent tumor

Procedure: Re-resection

Best oncological treatment

Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care

Drug: Temozolomide; Drug: Lomustine; Radiation: Re-irradiation; Procedure: Experimental therapy; Other: Best supportive care

Interventions

Re-resection PROCEDURE

Resection of the recurrent tumor

Re-resection

Temozolomide DRUG

Re-challenge Temozolomide chemotherapy

Best oncological treatment

Lomustine DRUG

Second line chemotherapy with Lomustine

Best oncological treatment

Re-irradiation RADIATION

Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor

Best oncological treatment

Experimental therapy PROCEDURE

Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)

Also known as: Immunotherapy, Oncolytic virotherapy

Best oncological treatment

Best supportive care OTHER

Best supportive care, focused on alleviating symptoms

Best oncological treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age ≥18 years and ≤90 years
• Tumor recurrence according to the RANO criteria of a previously diagnosed glioblastoma based on the WHO 2021 classification for glioma
• The tumor is suitable for resection (according to neurosurgeon)
• Written informed consent

You may not qualify if:

• Tumors of the cerebellum, brainstem, or midline
• Medical reasons precluding MRI (e.g., pacemaker)
• Inability to give written informed consent
• Secondary high-grade glioma due to malignant transformation from low-grade glioma
• Clinical data unavailable for the newly diagnosed setting

Sponsors & Collaborators

• Jasper Gerritsen: lead
• Haaglanden Medical Centre: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Hospital Heidelberg: collaborator
• Technical University of Munich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• Massachusetts General Hospital: collaborator
• University of California, San Francisco: collaborator

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

University Hospital Leuven

Leuven, Belgium

RECRUITING

University Hospital Heidelberg

Heidelberg, Germany

RECRUITING

Technical University Munich

Munich, Germany

NOT YET RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015 CE, Netherlands

RECRUITING

Medical Center Haaglanden

The Hague, South Holland, 2261 CP, Netherlands

RECRUITING

Inselspital Universitätsspital Bern

Bern, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Interventions

Temozolomide; Lomustine; Re-Irradiation; Therapies, Investigational; Immunotherapy; Oncolytic Virotherapy

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Radiotherapy; Therapeutics; Retreatment; Immunomodulation; Biological Therapy

Study Officials

• Jasper Gerritsen, MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jasper Gerritsen, MD PhD

CONTACT

31107036130; j.gerritsen@erasmusmc.nl

Arnaud Vincent, MD PhD

CONTACT

31107034211; a.vincent@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: January 1, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CH (1); DE (2); US (2); NL (2); BE (1)