NCT01717924招募中不适用
Multicenter Randomized Controlled Trial to Evaluate the Strategy of Primary Surgery Versus Primary Chemotherapy in Resectable Signet Ring Cell Gastric Adenocarcinoma (ADCI002 Study)
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2012年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 314
- 试验地点
- 2
- 主要终点
- Percentage of patients dead in the 2-years
研究概览
简要总结
The ADCI 002 trial is a large multicenter phase II-III prospective randomized controlled trial comparing primary surgery versus primary chemotherapy followed by surgery in patients with a resectable signet ring cell gastric adenocarcinoma
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenocarcinoma of the stomach or the oesogastric junction of type III of Siewert classification,histologically proven with the presence of signet ring cells (according to WHO 2000 classification) or diffuse form (according to Lauren classification) on pre-therapeutic biopsies
- •tumoural stage IB, II or III (according to UICC-AJCC 2009)
- •patient judged resectable in a curative intent on inclusion
- •absence of distant metastasis
- •absence of peritoneal carcinomatosis during pre-treatment explorative laparoscopy
- •WHO performance status 2 or less
- •age over 18 or under 80 years
- •weight loss at the time of inclusion < 15%
- •neutrophilic polynuclears more than 1500/mm3
- •platelets more than 100000/mm3
- •creatinine clearance more than 50 ml/min
- •serum-albumin more than 30 gram/l
- •bilirubin less than 1,5 normal
- •prothrombin rate over 80%
- •absence of prior treatment with chemotherapy or radiotherapy for gastric cancer
- •absence of kniwn child B or C cirrhosis
- •left ventricular ejection fraction more than 50% before epirubicin treatment
- •extension check-up performed within 4 weeks of inclusion
- •signed written informed consent given by the patient
排除标准
- •no corresponding to the inclusion criteria
- •another malignant tumour treated for curative purposes during the past 5 years excepted basocellular skin carcinoma or in situ uterine cervix cancer
- •allergy to the active substance or one of the excipients in the study drugs
- •pregnancy or breast-feeding
- •any other concommitant treatment, immunotherapy or hormonal therapy
- •history of abdominal or chest radiotherapy
- •any evolving disorder which is not under control (liver failure, kidney failure, respiratory failure, evolving heart failure or myocardial necrosis during the past 6 months)
- •patients who cannot be regularly monitored
研究组 & 干预措施
peri-operative chemotherapy
Active Comparator
Neoadjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5 fluoro-uracil (oral or intra-veinous) Surgery within 3 and 6 weeks after the end of neoadjuvant chemotherapy Adjuvant chemotherapy with 3 cycles of the same chemotherapy within 6 and 12 weeks after surgery
干预措施: peri-operative chemotherapy (Procedure)
surgery first with adjuvant chemotherapy
Experimental
Surgery first Adjuvant chemotherapy with 3 cycles of Epirubicin/Cisplatin/5FU within 6 and 12 weeks after surgery No neoadjuvant chemotherapy
干预措施: Surgery first (Procedure)
结局指标
主要结局
Percentage of patients dead in the 2-years
时间窗: 2 years
次要结局
- grade III/IV toxicity(2 years)
- post operative morbi-mortality(2 years)
- Average of patients who benefit from the overall treatment strategy(2 years)
- Overall survival at 3 years(3 years)
- R0 resection rate(within 1 year)
- Disease-free survival at 2 years(2 years)
- Disease-free survival at 3 years(3 years)
- quality of life(2 years)
- emotional status(2 years)
研究者
研究点 (2)
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