TY - JOUR
T1 - CRITICS-II
T2 - 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
AU - Slagter, Astrid E
AU - Jansen, Edwin P M
AU - van Laarhoven, Hanneke W M
AU - van Sandick, Johanna W
AU - van Grieken, Nicole C T
AU - Sikorska, Karolina
AU - Cats, Annemieke
AU - Muller-Timmermans, Pietje
AU - Hulshof, Maarten C C M
AU - Boot, Henk
AU - Los, Maartje
AU - Beerepoot, Laurens V
AU - Peters, Frank P J
AU - Hospers, Geke A P
AU - van Etten, Boudewijn
AU - Hartgrink, Henk H
AU - van Berge Henegouwen, Mark I
AU - Nieuwenhuijzen, Grard A P
AU - van Hillegersberg, Richard
AU - van der Peet, Donald L
AU - Grabsch, Heike I
AU - Verheij, Marcel
PY - 2018
Y1 - 2018
N2 - 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.
AB - 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.
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Chemoradiotherapy, Adjuvant/methods
KW - Chemotherapy, Adjuvant/methods
KW - Combined Modality Therapy
KW - Female
KW - Follow-Up Studies
KW - Gastrectomy/methods
KW - Humans
KW - Male
KW - Neoadjuvant Therapy/methods
KW - Neoplasm Grading
KW - Neoplasm Metastasis
KW - Neoplasm Staging
KW - Quality of Life
KW - Stomach Neoplasms/mortality
KW - Treatment Outcome
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85057519553&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30200910
U2 - https://doi.org/10.1186/s12885-018-4770-2
DO - https://doi.org/10.1186/s12885-018-4770-2
M3 - Article
C2 - 30200910
SN - 1471-2407
VL - 18
SP - 877
JO - BMC Cancer
JF - BMC Cancer
IS - 1
ER -