KCT0005790尚未招募未知
A multicenter prospective phase II comparative study of laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for the treatment of locally advanced gastric cancer patients
Chonnam National University Hospital Hwasun Hospital0 个研究点目标入组 238 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 238
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1.Patients who voluntarily expressed their consent to participate in this trial by signing a written ‘Subject Consent Form.’
- •2.Patients whose gastric adenocarcinoma located in the middle or lower part of the stomach is histologically confirmed and deemed possible to perform a radical distal gastrectomy surgery.
- •3.Patients who come under T2/N(+)M0, T3~4a/N(- or +) M0 according to the 8th edition of the TNM classification.
排除标准
- •Methodologies
- •1.Patients less than 20 years old or older than 80 years old
- •2.Eastern Cooperative Oncology Group(ECOG) = 2
- •3.Patients with a surgery experience due to a neoplasm in the stomach.
- •4.Patients with complications due to gastric cancer (acute hemorrhage, gastric outlet obstruction or perforation)
- •5.Patients with distant metastases (M1) including distant lymph nodes (Retropancreatic, para-aortic, periportal, retroperitoneal, or mesenteric lymph nodes)
- •6.Patients without distant metastases but who are, according to a surgeon’s judgment, unqualified for radical gastrectomy because of invasions to adjacent organs (T4b).
- •7.In the case of localized conglomerated metastatic lymph nodes
- •8.Patients who received surgery or radiation therapy for a primary cancer developed in another organ or those with active/synchronous double cancer in recent 5 years.
- •9.Patients who participated in another clinical trial or was administered with a different investigational drug in 30 days prior to randomization.
- •10.Patients who had any of the following in 6 months before the trial recruitment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass surgery, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack.
- •11.Patients with a previous experience of uncontrolled seizure, central nervous system or psychological disorders whose conditions are clinically significant to the extent that they are unable to express consent to participate in the trial and oral drug administration is not possible.
- •12.Patients with uncontrolled active infection or sepsis.
- •13.Patients who had deep vein thrombosis in recent 4 weeks before the beginning of the trial recruitment.
- •14.Patients with serious acute or chronic disease that can degrade the patient’s ability to participate in the trial or impede the interpretation of the trial results.
- •15.Pregnant or breast-feeding patients. Fertile female patients who are positive in pregnancy test.
- •Drug Administration for Neoadjuvant Chemotherapy
- •16.Inadequate functions of marrow or organs:
- •I.Absolute Neutrophil Count (ANC) < 1.5 x 109/L
- •II.Platelet (PLT) < 100 x 109/L
- •III.Hemoglobin (Hb) = 9 g/dL
- •IV.AST> 2.5 x ULN, ALT> 2.5 x ULN
- •V.ALP > 2.5 x ULN
- •VI.Total Bilirubin (T. Bil) > 1.5 x ULN
- •VII.Serum creatinine (Cr) > 1.5 x ULN
- •17.Patients who have peripheral neuropathy with clinical signs of Grade=2 (NCI CTCAE v4.03) or with absence of deep tension reflex (DTR).
- •18.Patients with hypersensitivity history of the investigational drug (5-FU, Oxaliplatin, Docetaxel).
- •19.Patients who are on treatment with warfarin or coumarin anticoagulants.
- •20.Patients who are on immunosuppressive therapy.
- •21.Patients who are receiving co-medication with Cytochrome P450 2A6 inducer, inhibitor, and substrate.
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