A Randomized Single Center Controlled Study of Perioperative Chemotherapy of Oxaliplatin Combined With Capecitabine (XELOX) Versus XELOX as Post-operative Chemotherapy in Advanced Gastric Adenocarcinoma With D2 Dissection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 3-year DFS
研究概览
简要总结
The purpose of this study is to demonstrate that capecitabine/oxaliplatin as perioperative chemotherapy is superior or not to operation directly for locally advanced gastric cancer in terms of 3 year disease-free survival (DFS) rate.
详细描述
The patients of gastric cancer have been divided into two parts in random.The test group receive perioperative chemotherapy (XELOX) six cycles and the control group administrate the same program after operation. The two groups have the same staging and eligibility criteria.The 3 year disease-free survival (DFS) rate and 5 year overall survival (OS) rate maybe the last evaluation standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Karnofsky performance status of ≥60 %.
- •Histologically confirmed gastric adenocarcinoma, staged pathologically or clinically, stage cT2-4N+M0, and cT4N0M
- •Patients had to have adequate renal function (serum creatinine ≤1 times the upper limit of normal [ULN]), hepatic function (total bilirubin ≤1·5 times the ULN, aspartate or alanine aminotransferase ≤2·5 times the ULN, alkaline phosphatase ≤2·5 times the ULN, Serum albumin ≥30g/L), and haematological function (absolute neutrophil count ≥1·5×10⁹/L and platelet count ≥100×10⁹/L)
排除标准
- •Pregnant or lactating women.
- •According to the AJCC TMN 7.0, Any evidence of metastatic (TxNxM1) patients(including presence of tumor cells in the ascites).
- •Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- •Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- •Has uncontrolled epilepsy, central nervous system diseases or mental disorders of history.
- •Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
- •Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
- •Known peripheral neuropathy ≥ CTCAEv3 grade 1 (Common Terminology for Adverse Events). Absence of deep tendon reflexes as the sole neurologic abnormality does not render the patient ineligible.
- •Organ allografts requiring immunosuppressive therapy.
- •Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- •Moderate or severe renal impairment [creatinine clearance equal to or below 50 ml/min (calculated according to Cockroft and Gault)], or serum creatinine > 1.5 x upper limit of normal (ULN).
- •Any of the following laboratory values:
- •Absolute neutrophil count (ANC) < 1.5 x 109/L
- •Platelet count < 100 x 109/L
- •Total bilirubin > 1.5 x ULN
- •ALAT, ASAT > 2.5 x ULN
- •Alkaline phosphatase > 2.5 x ULN.
- •Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
- •Hypersensitivity to platinum compounds or any of the components of the study medications.
- •Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
XELOX adjuvant group
D2 resection
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles
干预措施: Capecitabine (Drug)
XELOX adjuvant group
D2 resection
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles
干预措施: Oxaliplatin (Drug)
XELOX adjuvant group
D2 resection
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 6 cycles
干预措施: D2 resection (Procedure)
XELOX neoadjuvant
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.
D2 resection
After operation:
CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.
干预措施: Capecitabine (Drug)
XELOX neoadjuvant
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.
D2 resection
After operation:
CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.
干预措施: Oxaliplatin (Drug)
XELOX neoadjuvant
XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy before operation.
D2 resection
After operation:
CR/PR: XELOX (Drug: Capecitabine 1,000 mg/m² twice daily. Film coated tablets of 500 mg. d1-14 q3w Drug: Oxaliplatin IV infusion, 130mg/m² d1 q3w) 3 cycles chemotherapy after operation. SD/PD:,ST(Drug: S-1，40-75mg twice daily. d1-14 q3w Drug: Paclitaxel IV infusion 135mg/m2 d1; q3w) 3 cycles chemotherapy after operation.
干预措施: D2 resection (Procedure)
结局指标
主要结局
3-year DFS
时间窗: 3 years after surgery
次要结局
- adverse events(From date of randomization until the end of the study, assessed up to 5 years)
- response rate(evaluate after the end of neoadjuvant chemotherapy ie within 1 weeks after the neoadjuvant therapy)
- R0 resection rate(after the pathological examination of resected speciments ie within 1 month after the operation)
- overall survival(5 years after surgery)
研究者
Yingwei Xue
Chief of Gastrointestinal Surgery
Harbin Medical University