CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-09-10

AUTHORS

Astrid E. Slagter, Edwin P. M. Jansen, Hanneke W. M. van Laarhoven, Johanna W. van Sandick, Nicole C. T. van Grieken, Karolina Sikorska, Annemieke Cats, Pietje Muller-Timmermans, Maarten C. C. M. Hulshof, Henk Boot, Maartje Los, Laurens V. Beerepoot, Frank P. J. Peters, Geke A. P. Hospers, Boudewijn van Etten, Henk H. Hartgrink, Mark I. van Berge Henegouwen, Grard A. P. Nieuwenhuijzen, Richard van Hillegersberg, Donald L. van der Peet, Heike I. Grabsch, Marcel Verheij

ABSTRACT

BackgroundAlthough radical surgery remains the cornerstone of cure in resectable gastric cancer, survival remains poor. Current evidence-based (neo)adjuvant strategies have shown to improve outcome, including perioperative chemotherapy, postoperative chemoradiotherapy and postoperative chemotherapy. However, these regimens suffer from poor patient compliance, particularly in the postoperative phase of treatment. The CRITICS-II trial aims to optimize preoperative treatment by comparing three treatment regimens: (1) chemotherapy, (2) chemotherapy followed by chemoradiotherapy and (3) chemoradiotherapy.MethodsIn this multicentre phase II non-comparative study, patients with clinical stage IB-IIIC (TNM 8th edition) resectable gastric adenocarcinoma are randomised between: (1) 4 cycles of docetaxel+oxaliplatin+capecitabine (DOC), (2) 2 cycles of DOC followed by chemoradiotherapy (45Gy in combination with weekly paclitaxel and carboplatin) or (3) chemoradiotherapy. Primary endpoint is event-free survival, 1 year after randomisation (events are local and/or regional recurrence or progression, distant recurrence, or death from any cause). Secondary endpoints include: toxicity, surgical outcomes, percentage radical (R0) resections, pathological tumour response, disease recurrence, overall survival, and health related quality of life. Exploratory endpoints include translational studies on predictive and prognostic biomarkers.DiscussionThe aim of this study is to select the most promising among three preoperative treatment arms in patients with resectable gastric adenocarcinoma. This treatment regimen will subsequently be compared with the standard therapy in a phase III trial.Trial registrationclinicaltrials.gov NCT02931890; registered 13 October 2016. Date of first enrolment: 21 December 2017. More... »

PAGES

877

References to SciGraph publications

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  • Journal

    TITLE

    BMC Cancer

    ISSUE

    1

    VOLUME

    18

    Author Affiliations

  • Department of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
  • Department of Medical Oncology, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands
  • Department of Surgery, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
  • Department of Pathology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands
  • Statistical Department, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
  • Department of Gastroenterology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands
  • Department of Radiation Oncology, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands
  • Department of Medical Oncology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands
  • Department of Medical Oncology, St. Elisabeth Hospital, Hilvarenbeekse Weg 60, 5022 GC, Tilburg, The Netherlands
  • Department of Medical Oncology, Zuyderland Sittard-Geleen, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands
  • Department of Medical Oncology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands
  • Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands
  • Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands
  • Department of Surgery, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands
  • Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands
  • Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3484 CX, Utrecht, The Netherlands
  • Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands
  • Department of Pathology & Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s12885-018-4770-2

    DOI

    http://dx.doi.org/10.1186/s12885-018-4770-2

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1106903985

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30200910


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