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SUPRAMAX-study: supramaximal resection versus maximal resection for glioblastoma patients: study protocol for an international multicentre prospective cohort study (ENCRAM 2201).
Gerritsen, Jasper Kees Wim; Young, Jacob S; Chang, Susan M; Krieg, Sandro M; Jungk, Christine; van den Bent, Martin J; Satoer, Djaina D; Ille, Sebastian; Schucht, Philippe; Nahed, Brian V; Broekman, Marike Lianne Daphne; Berger, Mitchel; De Vleeschouwer, Steven; Vincent, Arnaud J P E.
Afiliación
  • Gerritsen JKW; Neurosurgery, Erasmus Medical Center, Rotterdam, The Netherlands j.gerritsen@erasmusmc.nl.
  • Young JS; Department of Neurosurgery, University of California San Francisco, San Francisco, California, USA.
  • Chang SM; Department of Neurosurgery, University of California San Francisco, San Francisco, California, USA.
  • Krieg SM; Department of Neurosurgery, University of California San Francisco, San Francisco, California, USA.
  • Jungk C; Department of Neurosurgery, University Hospital Heidelberg, Heidelberg, Baden-Württemberg, Germany.
  • van den Bent MJ; Neuro-oncology, UniversitatsKlinikum Heidelberg, Heidelberg, Germany.
  • Satoer DD; Department of Neuro Oncology, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
  • Ille S; Neurosurgery, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands.
  • Schucht P; Department of Neurosurgery, Technical University of Munich, Munich, Bayern, Germany.
  • Nahed BV; Neurosurgery, Inselspital Universitätsspital Bern, Bern, Switzerland.
  • Broekman MLD; Department of Neurosurgery, Massachusetts General Hospital, Boston, Massachusetts, USA.
  • Berger M; Neurosurgery, Medisch Centrum Haaglanden, Den Haag, The Netherlands.
  • De Vleeschouwer S; University of California San Francisco, San Francisco, California, USA.
  • Vincent AJPE; Neurosurgery, Katholieke Universiteit Leuven UZ Leuven, Leuven, Belgium.
BMJ Open ; 14(4): e082274, 2024 Apr 29.
Article en En | MEDLINE | ID: mdl-38684246
ABSTRACT

INTRODUCTION:

A greater extent of resection of the contrast-enhancing (CE) tumour part has been associated with improved outcomes in glioblastoma. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in high-grade glioma (HGG) patients in terms of survival, functional, neurological, cognitive and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively. METHODS AND

ANALYSIS:

This study is an international, multicentre, prospective, two-arm cohort study of observational nature. Consecutive glioblastoma patients will be operated with SMR or maximal resection at a 11 ratio. Primary endpoints are (1) overall survival and (2) proportion of patients with National Institute of Health Stroke Scale deterioration at 6 weeks, 3 months and 6 months postoperatively. Secondary endpoints are (1) residual CE and NCE tumour volume on postoperative T1-contrast and FLAIR (Fluid-attenuated inversion recovery) MRI scans; (2) progression-free survival; (3) receipt of adjuvant therapy with chemotherapy and radiotherapy; and (4) quality of life at 6 weeks, 3 months and 6 months postoperatively. The total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. ETHICS AND DISSEMINATION 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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Neoplasias Encefálicas / Glioblastoma Límite: Humans Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Neoplasias Encefálicas / Glioblastoma Límite: Humans Idioma: En Revista: BMJ Open Año: 2024 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido