Clinical trial · Observational
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, Malignant | Anaplastic Astrocytoma | ALIAS | 0.90 |
| Astrocytoma of Brain | — | UNRESOLVED | — |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma, IDH-wildtype | Glioblastoma, IDH-Wildtype | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme, Adult | Adult Glioblastoma | ALIAS | 0.90 |
| Glioblastoma Multiforme of Brain | Brain Glioblastoma | ALIAS | 0.90 |
| Recurrent Glioblastoma | Glioblastoma |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive care | Other | — | UNRESOLVED |
| Experimental therapy | Procedure | — | UNRESOLVED |
| Lomustine | Drug | Lomustine | ALIAS |
| Re-irradiation | Radiation | — | UNRESOLVED |
| Re-resection | Procedure | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Re-resection
- description
- Resection of the recurrent tumor
- interventionNames
- Procedure: Re-resection
- label
- Best oncological treatment
- description
- Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care
- interventionNames
- Drug: Temozolomide
- Drug: Lomustine
- Radiation: Re-irradiation
- Procedure: Experimental therapy
- Other: Best supportive care
Primary outcomes (2)
- measure
- Overall survival
- timeFrame
- Up to 5 years postoperatively
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available