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
Overview
- Phase
- Phase 3
- Intervention
- docetaxel plus oxaliplatin and capecitabine
- Conditions
- Stomach Neoplasms
- Sponsor
- LiNing
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- disease free survival
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
LiNing
Chief Physician
Henan Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Have signed the informed consent and can comply with the visit and related procedures stipulated in the program
- •Age ≥18 years old and ≤75 years old
- •D2 radical resection was performed within 21-60 days before the beginning of the first cycle of chemotherapy in this clinical study
- •Preoperative neoadjuvant chemotherapy was not performed and Gastric and gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were confirmed by postoperative pathological staging. Note: the presence of distant metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be performed
- •Postoperative ECOG score was 0 or 1
- •Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and hemoglobin ≥ 90 g/L
- •Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of normal value
- •Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45 ml/min
- •Serum albumin ≥ 25 g/L (2.5g /dL)
- •INR or PT ≤ 1.5 times ULN
Exclusion Criteria
- •Postoperative wound healing is poor and chemotherapy is not appropriate to start
- •Recurrent patients or suspected peritoneal metastases after radical surgery
- •Known DPD enzyme deficiency
- •Allergy to, or history of severe allergy to, or contraindication to any of the experimental drugs or its excipients
- •Patients who are expected to require major surgery during the study period
- •Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia
- •Tested positive for HIV
- •Active hepatitis b or c
- •Only liquid diet was allowed after the operation, with BMI \<18kg/m2
- •Uncontrolled pain
Arms & Interventions
experimental group
docetaxel plus oxaliplatin and capecitabine
Intervention: docetaxel plus oxaliplatin and capecitabine
control group
oxaliplatin plus capecitabine
Intervention: oxaliplatin plus capecitabine
Outcomes
Primary Outcomes
disease free survival
Time Frame: up to three years.
From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.
Secondary Outcomes
- Adverse reaction(up to three years.)
- overall survival(up to three years.)
- Assessment of life quality(up to three years.)