The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma: Study Protocol for An International Multicenter Prospective Cohort Study (ENCRAM 2302)
Jasper Gerritsen
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.
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 mont…
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- Not specified
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 settin…
Interventions
- ProcedureRe-resection
Resection of the recurrent tumor
- DrugTemozolomide
Re-challenge Temozolomide chemotherapy
- DrugLomustine
Second line chemotherapy with Lomustine
- RadiationRe-irradiation
Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor
- ProcedureExperimental therapy
Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)
- OtherBest supportive care
Best supportive care, focused on alleviating symptoms
Locations (8)
- University of California, San FranciscoSan Francisco, California
- Massachusetts General HospitalBoston, Massachusetts
- University Hospital LeuvenLeuven
- University Hospital HeidelbergHeidelberg
- Technical University MunichMunich
- Erasmus MCRotterdam, South Holland