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RESURGE - Randomized controlled comparative phase II trial on surgery for glioblastoma recurrence

English title RESURGE - Randomized controlled comparative phase II trial on surgery for glioblastoma recurrence
Applicant Schucht Philippe
Number 159648
Funding scheme Project funding (Div. I-III)
Research institution Inselspital Bern Neurochirurgie
Institution of higher education University of Berne - BE
Main discipline Clinical Cancer Research
Start/End 01.07.2015 - 30.06.2019
Approved amount 314'088.00
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All Disciplines (3)

Discipline
Clinical Cancer Research
Surgery
Neurophysiology and Brain Research

Keywords (5)

Quality of life; Survival; Recurrent glioblastoma; Brain Tumor Surgery; CRET

Lay Summary (German)

Lead
Glioblastom bezeichnet einen malignen hirneigenen Tumor. Die Standardtherapie besteht aus der operativen Entfernung der Tumorhauptmasse gefolgt von einer kombinierten Radiochemotherapie. Trotz dieser intensiven Behandlung kommt es bei vielen Patienten innert Monaten zum Wiederauftreten des Tumors. In dieser Situation stehen zwei etablierte Behandlungskonzepte zur Verfügung: 1. Erneute Operation des Hirntumors, gefolgt von Zweitlinien-Therapie (Chemo- oder Radiotherapie)2. Sofortige Zweitlinien-Therapie (Chemo- oder Radiotherapie) ohne vorgängige OperationWelche der beiden Behandlungsstrategien den grösseren Einfluss auf die Überlebenszeit hat ist bisher ungeklärt. Die RESURGE Studie soll hierüber Klarheit verschaffen.
Lay summary

Inhalte und Ziel des Forschungsprojekts

Das Glioblastom ist der häufigste und bösartigste hirneigene Tumor. Als Standardtherapie nach Erstdiagnose gilt die operative Entfernung des Tumors, soweit es die Lage des Tumors zulässt. Anschliessend erhalten die Patienten eine kombinierte Chemo- und Radiotherapie. Trotz dieser intensiven Therapie treten Glioblastome wieder auf (durchschnittlich 4-8 Monate nach Abschluss der Bestrahlung). In dieser Situation stehen zwei Behandlungskonzepte zur Verfügung: Sowohl eine weitere Operation gefolgt von einer Zweitlinien-Therapie (Chemo- oder Radiotherapie), wie auch eine direkte Zweitlinien-Therapie (Chemo- oder Radiotherapie) können dazu beitragen, das Glioblastom zurück zu drängen.
Bis heute ist unklar, ob eine erneute Operation eines wiederaufgetretenen Glioblastoms das Überleben der Patienten verlängert. Einige Analysen zeigen ermutigende Resultate nach erneuter Operation, wobei andere Analysen denselben Behandlungserfolg für beiden Therapiekonzepte aufzeigen.

Ziel dieser klinischen Studie ist es, die Therapie von wiederaufgetretenen Glioblastomen zu verbessern, indem wir untersuchen, ob durch eine erneute Operation die Überlebenszeit verlängert werden kann und wie sich die Operation auf die Lebensqualität auswirkt.

Wissenschaftlicher und gesellschaftlicher Kontext des Forschungsprojektes

Mit dieser Studie kann der relative Nutzen der beiden Therapiestrategien auf die Überlebenszeit und die Lebensqualität der Patienten erstmals zuverlässig abgeschätzt werden.

Direct link to Lay Summary Last update: 03.06.2015

Responsible applicant and co-applicants

Employees

Project partner

Collaboration

Group / person Country
Types of collaboration
Prof. Monika Hegi, CHUV, Department of Neurosurgery, Translational research lab Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
PhD Thierry Gorlia, European Organization of Research and treatment of Cancer Belgium (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Prof. Dr. Mauricio Reyes, University Bern, Institute of Surgical Technology and Biomechanics (ITSB) Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Prof. Dr. med. Luca Regli, University Hospital Zurich, Departments of Neurooncology and Neurosurgery Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Prof. Dr. med. Elisabeth Rushing, University of Zurich, Department of Neuropathology Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
Prof. Dr. Roland Wiest, Inselspital Bern, Institute of Diagnostic and Interventional Neuroradiology Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure

Associated projects

Number Title Start Funding scheme
140958 Establishing Novel MR Criteria for the Assessment of Malignant Glioma Progression 01.10.2012 Project funding (Div. I-III)

Abstract

BackgroundMaximal safe resection is standard treatment for newly diagnosed glioblastoma, and a complete resection of enhancing tumor is thought to significantly prolong survival. Patients are recommended to undergo adjuvant and concomitant radio-chemotherapy, which further prolongs survival. However, glioblastoma almost invariably recurs after a median of 6.9 months, leaving few options for further treatment. Various second-line pharmaco- and radiotherapies may be used, but none have been shown to prolong survival in a randomized trial. Repetition of tumor resection at recurrence before second line therapy is often offered, and 1 out of 4 patients with glioblastoma will undergo more than one resection. However, the impact of surgery for recurrent glioblastoma on survival is very controversial. A series of retrospective analyses report an apparent survival benefit after multiple resections. On the other hand, an EORTC (European Organization for Research and Treatment of Cancer) meta-analysis on second-line therapies on 300 patients found no survival difference in patients with or without surgery at recurrence. Re-operation of glioblastoma may lead to neurological deficits in up to 16% of cases in the current literature, with a potentially detrimental effect on the quality-of-life. Further evidence of the effect of re-operation on survival and neurological outcomes as well as quality-of-life is therefore needed.AimThe purpose of this randomized trial is to assess the effect of re-operation of recurrent tumor followed by second-line therapy versus non-surgical second-line therapy alone on survival outcomes, neurological out-come and quality of life. Results may provide evidence to support a subsequent randomized controlled phase III trial for resection of glioblastoma recurrence in cooperation with the EORTC.MethodologyThis is a multicenter, randomized (2:1), parallel-group, controlled, non-blinded, comparative phase II trial in patients with first recurrent glioblastoma. All patients will be randomized into 1) the surgical group: cranioto-my and resection of contrast-enhancing tumor followed by adjuvant second-line therapy, or 2) the non-surgical/control group: non-surgical therapy alone. Follow-up visits are scheduled every 3 months after study inclusion up to 24 months or death, and includes cerebral MRI, physical examination and assessment of quality of life. Primary outcome is overall survival from the date of randomization up to the date of death. The sample size was calculated as 120 in order to reach the planned treatment effect (HR=0.58) with 90% power at 10% significance.Potential significanceThe study will provide insight into the influence of surgery on survival and may therefore impact treatment strategies for recurrent glioblastoma. Furthermore, the study`s survival data will improve sample size estima-tion for a subsequent phase III trial (anticipated and planned by the Swiss Glioma Network and the EORTC).
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