A Phase II Study of Neoadjuvant Chemotherapy With Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
The purpose of this study is to determine whether docetaxel, capecitabine, cisplatin, and bevacizumab are effective in the treatment of unresectable advanced gastric cancer.
详细描述
In our previous phase II study of neoadjuvant docetaxel, capecitabine and cisplatin chemotherapy, patients with unresectable gastric cancer because of invasion to adjacent organs or metastasis to para-aortic lymph nodes received benefit from neoadjuvant chemotherapy. Based on these results and reports that bevacizumab enhances response rate, we planned docetaxel, capecitabine, cisplatin, and bevacizumab as neoadjuvant chemotherapy for patients with local invasion or para-aortic node metastasis alone.
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 documented adenocarcinoma of the stomach or gastroesophageal junction.
- •Invasion to adjacent organ (T4) proven by endoscopic ultrasonography (EUS) or presence of paraaortic lymph node metastasis by CT and PET(short-axis diameter > 1 cm showing hot uptake in PET scan).
- •Age 18-70 years old
- •ECOG performance status 0-2
- •Adequate hepatic function(serum bilirubin <1.5mg/dl, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL)
- •Adequate renal function(serum creatinine <1.5mg/dl)
- •Adequate bone marrow function (WBC ≥4000 cell/㎕ with ANC ≥1500 cell/㎕, platelet count ≥100,000 cell/㎕)
- •HER2 negative (HER2 immunohistochemistry 0 or 1+, immunohistochemistry 2+ but FISH negative)
- •Informed consent
排除标准
- •Other histologic type than adenocarcinoma
- •Metastasis in other sites than paraaortic lymph nodes, like in liver or peritoneum.
- •Presence or history of other cancers
- •History of prior chemotherapy, antiangiogenic agents, or radiation.
- •Patients with definite ascites in abdomen CT scan
- •Presence of not adequately controlled CNS metastasis
- •Bowel obstruction
- •Evidence of gastrointestinal bleeding
- •Other serious illness or medical conditions including hypertension uncontrolled by medication.
- •Pregnant or lactating women
研究组 & 干预措施
neoadjuvant
干预措施: Docetaxel, Capecitabine, Cisplatin, Bevacizumab (Drug)
结局指标
主要结局
R0 resection rate
时间窗: Up to 4 weeks after surgery
R0 resection means complete resection of tumor.
次要结局
- Overall survival(Up to 3 years)
- Progression-free survival(Up to 3 years)
- Adverse Event(Up to 28 days after end of treatment)
- Angiogenetic biomarkers(Baseline and 6 weeks after treatment)
研究者
Yoon-Koo Kang
Professor
Asan Medical Center