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 - Henegouwen, Mark I. van Berge
AU - Nieuwenhuijzen, Grard A. P.
AU - van Hillegersberg, Richard
AU - van der Peet, Donald L.
AU - Grabsch, Heike I.
AU - Verheij, Marcel
PY - 2018/9/10
Y1 - 2018/9/10
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.
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.
KW - Gastric cancer
KW - Resectable
KW - Preoperative treatment
KW - Chemotherapy
KW - Chemoradiotherapy
KW - Surgery
KW - LYMPH-NODE DISSECTION
KW - ADJUVANT CHEMOTHERAPY
KW - CLINICAL-TRIAL
KW - PLUS CISPLATIN
KW - D2 GASTRECTOMY
KW - PREOPERATIVE CHEMORADIOTHERAPY
KW - PERIOPERATIVE CHEMOTHERAPY
KW - GASTROESOPHAGEAL JUNCTION
KW - CURATIVE RESECTION
KW - OPEN-LABEL
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Neoplasm Metastasis
KW - Neoplasm Grading
KW - Chemoradiotherapy, Adjuvant/methods
KW - Female
KW - Neoadjuvant Therapy/methods
KW - Stomach Neoplasms/mortality
KW - Treatment Outcome
KW - Combined Modality Therapy
KW - Chemotherapy, Adjuvant/methods
KW - Quality of Life
KW - Neoplasm Staging
KW - Gastrectomy/methods
U2 - 10.1186/s12885-018-4770-2
DO - 10.1186/s12885-018-4770-2
M3 - Article
C2 - 30200910
SN - 1471-2407
VL - 18
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 877
ER -