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

Part of paid clinical trials in San Francisco, California.

Sponsor
Jasper Gerritsen
Study ID
NCT06283927
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Re-resection — PROCEDURE
    Resection of the recurrent tumor
  • Temozolomide — DRUG
    Re-challenge Temozolomide chemotherapy
  • Lomustine — DRUG
    Second line chemotherapy with Lomustine
  • Re-irradiation — RADIATION
    Re-irradiation with single dose, fractionated, or hypofractionated radiation of the recurrent tumor
  • Experimental therapy — PROCEDURE
    Experimental phase I therapy with oncolytic virotherapy or immunotherapy (this list is not exhaustive)
  • Best supportive care — OTHER
    Best supportive care, focused on alleviating symptoms

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Feb 2024
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
464 participants (estimated)

Arms

  • Arm: Re-resection
    Resection of the recurrent tumor
  • Arm: Best oncological treatment
    Best oncological treatment consisting of re-challenge temozolomide, re-irradiation, experimental therapy, or best supportive care

Primary Outcome Measure

Overall survival [ Time Frame: Up to 5 years postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Mitchel Berger, MD PhD
Massachusetts General HospitalBostonMassachusetts02114
Brian Nahed, MD PhD

Find similar trials in San Francisco, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, San Francisco· San Francisco, CAMassachusetts General Hospital· Boston, MA

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