BMC Cancer (Sep 2018)

CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer

  • 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

DOI
https://doi.org/10.1186/s12885-018-4770-2
Journal volume & issue
Vol. 18, no. 1
pp. 1 – 12

Abstract

Read online

Abstract Background Although 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. Methods In 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. Discussion The 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 registration clinicaltrials.gov NCT02931890; registered 13 October 2016. Date of first enrolment: 21 December 2017.

Keywords