This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.
In 2019, CSCO guidelines grade I recommend gastric or gastroesophageal junction adenocarcinoma patients, after D2 R0 resection, whose postoperative pathological stage was III treated with XELOX as an adjuvant chemotherapy. However, some retrospective clinical studies in China suggest that the 3-year DFS rate of XELOX program as an adjuvant postoperative chemotherapy program is still low, and the risk of recurrence is higher for patients with postoperative pathological stage IIIB/IIIC.In recent years, the success of the JACCRO GC-07 trial has provided evidence for the value of Taxoids in postoperative adjuvant therapy of gastric cancer. In the FLOT4 trial, the FLOT improved the DFS rate by 3 years compared with the ECF/ECX. At present, there is no clinical study data to prove whether the combined three-drug regimen can further reduce the risk of postoperative recurrence and improve the treatment effect compared with oxaliplatin combined capecitabine two-drug regimen for patients with high postoperative recurrence risk (patients with postoperative pathological stage IIIB/IIIC). Therefore, the investigators carried out this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d
oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d
Henan Cancer Hospital
Zhengzhou, Henan, China
disease free survival
From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.
Time frame: up to three years.
overall survival
From the date of randomization until the date of the first recorded death from any cause. For subjects lost to follow-up prior to death, the last follow-up time is usually calculated as the time of death.
Time frame: up to three years.
Adverse reaction
Adverse reaction will be assessed by NCI CT CAE v5.0.
Time frame: up to three years.
Assessment of life quality
Quality of life will be assessed using The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cancer (QLQ-C30) and the site-specific module for gastric cancer (QLQ-STO22) . These tables will be usde together to assessed the quality of life of the patients. The higher the score, the worse the quality of life.
Time frame: up to three years.
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