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

• Published in: BMC cancer Vol. 18; no. 1; p. 877
• Main Authors: Slagter, Astrid E, Jansen, Edwin P M, van Laarhoven, Hanneke W M, van Sandick, Johanna W, van Grieken, Nicole C T, Sikorska, Karolina, Cats, Annemieke, Muller-Timmermans, Pietje, Hulshof, Maarten C C M, Boot, Henk, Los, Maartje, Beerepoot, Laurens V, Peters, Frank P J, Hospers, Geke A P, van Etten, Boudewijn, Hartgrink, Henk H, van Berge Henegouwen, Mark I, Nieuwenhuijzen, Grard A P, van Hillegersberg, Richard, van der Peet, Donald L, Grabsch, Heike I, Verheij, Marcel
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 10.09.2018; BioMed Central; BMC
• Subjects: Adenocarcinoma; Adjuvant chemotherapy; Analysis; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer therapies; Carboplatin; Care and treatment; Chemoradiotherapy; Chemoradiotherapy, Adjuvant - methods; Chemotherapy; Chemotherapy, Adjuvant - methods; Clinical trials; Combined Modality Therapy; Comparative analysis; Female; Follow-Up Studies; Gastrectomy - methods; Gastric cancer; Humans; Male; Neoadjuvant Therapy - methods; Neoplasm Grading; Neoplasm Metastasis; Neoplasm Staging; Oxaliplatin; Paclitaxel; Patients; Perioperative care; Preoperative treatment; Quality of Life; Radiation therapy; Radiotherapy; Resectable; Stomach cancer; Stomach Neoplasms - mortality; Stomach Neoplasms - pathology; Stomach Neoplasms - therapy; Study Protocol; Surgery; Surgical outcomes; Survival; Toxicity; Treatment Outcome; Tumors; United Kingdom > UK; Netherlands; Japan; Chemotherapy; Resectable; Chemoradiotherapy; Gastric cancer; Surgery; Preoperative treatment
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-018-4770-2

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. 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. 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. clinicaltrials.gov NCT02931890 ; registered 13 October 2016. Date of first enrolment: 21 December 2017.