jRCTs051180198进行中（未招募）不适用
A phase II study of systemic chemotherapy with S-1 and oxaliplatin followed by gastrectomy with D2 or D2 plus limited para-aortic lymph node sissection in HER2 negative advanced gastric or esophagogastric junction cancer with extensive lymph node metastasis. (SOX-D2 study)
未提供0 个研究点目标入组 35 人开始时间: 2018年5月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 75age old under（—）
- 性别
- All
入选标准
- •Histologically proven gastric adenocarcinoma
- •HER2 negative (IHC 0 or IHC 1+, or IHC 2+/FISH -)
- •One of the following conditions is fulfilled by enhanced CT
- •Paraaortic lymph node metastasis (No.16a2/ 16b1)
- •Bulky N (at least one node of 3 cm or more in diameter, or at least three consecutive nodes each of diameter 1.5 cm or more, along the coeliac, splenic, common or proper hepatic arteries or superior mesenteric vein.)
- •Both of No.16a2/ 16b1 and bulky lymph node metastasis
- •Thoracic/ abdominal/ pelvic enhanced CT reveals none of the following findings:
- •i) Mediastinal lymph node metastasis
- •ii) Lung metastasis
- •iii) Peritoneal metastasis
- •iv) Liver metastasis
- •v) Pleural effusion, ascites beyond the pelvis
- •vi) Paraaortic No. 16a1 or No. 16b2 swelling 1cm or greater
- •vii) Other distant metastases (except for No. 13, No. 16a2 or No. 16b1 metastasis)
- •Neither Borrmann type 4 nor large (8cm or more) type 3
- •Length of esophageal invasion less than or equal to 3cm
- •Not stump cancer of stomach.
- •Clinically no sign of distant metastasis
- •No liver or peritoneal metastasis and CY0 by laparoscopy or laparotomy for bypass surgery within 28 days before registration
- •Age between 20 and 75 at registration
- •Performance Status (ECOG) 0 or 1
- •No prior chemotherapy, radiotherapy or endocrinotherapy
- •No prior surgery for gastric carcinoma except for bypass surgery and endoscopic mucosal resection
- •Fair oral intake with or without bypass surgery
- •Adequate organ functions defined as indicated below;
- •i) WBC >= 4,000/mm3 and <= 12,000/mm3
- •ii) Neutrophils >= 4,000/mm3
- •iii) Hb >= 8.0 g/dl
- •iv) Platelet >= 100,000/mm3
- •v) AST <= 100IU
- •vi) ALT <= 100IU
- •vii) T.bil <= 1.5 mg/dL
- •viii) Creatinine <= 1.2 mg/dL
- •viii) Ccr >= 60 mL/min/body
- •Written informed consent
排除标准
- •Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal cancer
- •Women during pregnancy or breast-feeding
- •Severe mental disease
- •Under treatment with systemic steroid
- •HBs antigen positive
- •Under treatment with flucytosine, phenytoin, or warfarin
- •Allergy to iodine
- •History of hypersensitivity to oxaliplatin or S-1
- •Peripheral motor neuropathy or peripheral sensory neuropathy by any reason
- •Edema of limbs or trunk by any reason
- •Interstitial pneumonia, pulmonary fibrosis or severe emphysema.
- •Active bacterial or fungal infection
- •Past history of myocardial infarction or unstable angina pectoris within 6 months
- •Uncontrollable hypertension
- •Uncontrollable diabetes mellitus or routine administration of insulin
结局指标
主要结局
-
3-year overall survival
次要结局
未报告次要终点