NCT00343239已完成2 期
Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.
研究概览
简要总结
Study objectives:
To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically proven gastric adenocarcinoma diagnosis
- •Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement.
- •ECOG performance status between 0 and 2
- •Acceptable hematological profile :
- •WBC (White Blood Cell) count ≥4000/mm3
- •Platelet count ≥100 000 mm3
- •Hemoglobin ≥9 g/100 mL (if lower, may be included following transfusion)
- •Adequate renal function
- •Serum creatinine <1.2 mg/dl or calculated creatinine clearance in 24-hours urine >60 mL/min.
- •Adequate hepatic function
- •Bilirubin < UNL
- •Transaminases (ALT, AST) <2.5 x UNL
- •Alcaline phosphatase <2.5 x UNL
- •Adequate pulmonary function
- •Adequate cardiac function
- •No prior chemotherapy for gastric cancer
排除标准
- •Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma
- •Pregnant or lactating patients
- •Patients with brain, bone or other metastases; peritoneal involvement
- •Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry
- •Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years
- •Active infection and other serious disease
- •Any other experimental drugs within a 4-week period prior to the study
- •Contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs)
- •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
Docetaxel/Cisplatin/Fluorouracil (DCF)
Experimental
DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability
干预措施: Docetaxel (Drug)
Docetaxel/Cisplatin/Fluorouracil (DCF)
Experimental
DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability
干预措施: Cisplatin (Drug)
Docetaxel/Cisplatin/Fluorouracil (DCF)
Experimental
DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability
干预措施: Fluorouracil (Drug)
结局指标
主要结局
To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.
时间窗: 3 cycles
次要结局
未报告次要终点
研究者
研究点 (1)
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