The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
314
Usual treatment strategy for gastric adenocarcinoma
strategy with a surgical procedure first, without the usual peri-operative chemotherapy
General and digestive surgical department, Claude Huriez Hospital, University Hospital
Lille, France
RECRUITINGPercentage of patients dead in the 2-years
Time frame: 2 years
Disease-free survival at 2 years
Time frame: 2 years
Disease-free survival at 3 years
Time frame: 3 years
Overall survival at 3 years
Time frame: 3 years
R0 resection rate
Time frame: within 1 year
grade III/IV toxicity
tolerance will be measured by the rate and grade of chemotherapy's complications
Time frame: 2 years
post operative morbi-mortality
Time frame: 2 years
Average of patients who benefit from the overall treatment strategy
Time frame: 2 years
quality of life
Time frame: 2 years
emotional status
It will be assessed by quality of life questionnaire(QLQ-C30, QLQ-STO-22,SF-36) and emotional status questionnaire(CES-D, STAI-Y-A, Brief-IPQ, WCC, ICEC-R, CRA)
Time frame: 2 years
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