Phase 2 Study of Response Rate and Side Effects of Preoperative Chemotherapy With Docetaxel, Oxaliplatin and Capcitabine (TOX) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pathologic Response rate
研究概览
简要总结
Early stage diagnosis of gastric cancer has ensued different approaches in its resection strategies. In order to increase the proportion of cases that undergo radical resection and reduce the recurrence rate, different pre-operative treatments are introduced. Here, the investigators investigate an active preoperative chemotherapeutic regimen to in patients with locally advanced gastric cancer.
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
- •Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma
- •T3, T4 any N with non metastatic condition
- •Age 18 - 70 years
- •Performance status 0,1 according to ECOG criteria
- •Adequate bone marrow , liver and renal function
- •Hemoglobin ≥ 11 g/dl
- •Platelets ≥ 100000 / mm3
- •Absolute Neutrophil Count ≥ 1500/mm3
- •Normal Bilirubin
- •Normal Transaminases
- •Normal creatinin
- •Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease)
排除标准
- •Any metastatic disease, T1, T2, N0
研究组 & 干预措施
Pathological Response
干预措施: TOX (Drug)
结局指标
主要结局
Pathologic Response rate
时间窗: Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
A single expert pathologist evaluates the pathologic outcome of the chemotherapy regimen after the completion of courses. Participants are divided into 3 groups including complete pathologic response, partial pathologic response and pathologic stable disease.
次要结局
- clinical Response rate(Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol.)
研究者
Dr Seyed-Hossein Yahyazadeh-Jabari
Director of Clinical Research Center
Milad Hospital