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Gastrointestinal Diseases

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Capecitabine

Docetaxel

Oxaliplatin

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docetaxel plus oxaliplatin and capecitabine

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

oxaliplatin plus capecitabine

Ning Li, PhD

Ning LI, PhD

Suxia Luo, PhD

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.

A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

The Efficacy and Safety of Postoperative Chemotherapy With Docetaxel Plus Oxaliplatin and Capecitabine Versus Oxaliplatin Plus Capecitabine for Postoperative Pathological Stage IIIB/IIIC Gastric Adenocarcinoma: a Randomised, Phase 3 Trial

From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.

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.

Adverse reaction will be assessed by NCI CT CAE v5.0.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer	NCT04351867	Stomach Neoplas...	docetaxel plus ... oxaliplatin plu...	18 Years - 75 Years	Henan Cancer Hospital
A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer	NCT04351867	Stomach Neoplas...	docetaxel plus ... oxaliplatin plu...	18 Years - 75 Years	Henan Cancer Hospital

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