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.

Autor: Slagter AE; Department of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Jansen EPM; Department of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., van Laarhoven HWM; Department of Medical Oncology, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands., van Sandick JW; Department of Surgery, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., van Grieken NCT; Department of Pathology, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands., Sikorska K; Statistical Department, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Cats A; Department of Gastroenterology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Muller-Timmermans P; Department of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Hulshof MCCM; Department of Radiation Oncology, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands., Boot H; Department of Gastroenterology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands., Los M; Department of Medical Oncology, St. Antonius Hospital, Koekoekslaan 1, 3435 CM, Nieuwegein, The Netherlands., Beerepoot LV; Department of Medical Oncology, St. Elisabeth Hospital, Hilvarenbeekse Weg 60, 5022 GC, Tilburg, The Netherlands., Peters FPJ; Department of Medical Oncology, Zuyderland Sittard-Geleen, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands., Hospers GAP; Department of Medical Oncology, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands., van Etten B; Department of Surgery, University Medical Center Groningen, Hanzeplein 1, 9713 GZ, Groningen, The Netherlands., Hartgrink HH; Department of Surgery, Leiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands., van Berge Henegouwen MI; Department of Surgery, Academic Medical Center Amsterdam, Meibergdreef 9, 1106 AZ, Amsterdam, The Netherlands., Nieuwenhuijzen GAP; Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 EJ, Eindhoven, The Netherlands., van Hillegersberg R; Department of Surgery, University Medical Center Utrecht, Heidelberglaan 100, 3484 CX, Utrecht, The Netherlands., van der Peet DL; Department of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands., Grabsch HI; Department of Pathology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, P Debyelaan 25, 6229 HX, Maastricht, The Netherlands.; Department of Pathology & Tumour Biology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK., Verheij M; Department of Radiation Oncology, Netherlands Cancer Institute - Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. m.verheij@nki.nl.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2018 Sep 10; Vol. 18 (1), pp. 877. Date of Electronic Publication: 2018 Sep 10.
DOI: 10.1186/s12885-018-4770-2
Abstrakt: 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.
Databáze: MEDLINE
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