ISRCTN12206108已完成2 期
Efficacy and safety of oxaliplatin plus S-1 or capecitabine as neoadjuvant or adjuvant chemotherapy for locally advanced gastric cancer with D2 lymphadenectomy: a phase II-III randomized trial
Peking University Cancer Hospital & Institute0 个研究点目标入组 224 人开始时间: 2018年3月7日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
研究概览
简要总结
- 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30510363
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged between 18 and 80 years
- •2. Pathologically confirmed gastric adenocarcinoma
- •3. Disease at the clinical stage of resectable advanced gastric cancer (T2-4NanyM0), without peritoneal metastasis as confirmed by laparoscopy and cytological pathology
- •4. Eastern Cooperative Oncology Group performance status of 0 or 1
- •5. No previous treatment history
- •6. Adequate organ function levels (hematological ANC =1.5x10(9)/l, hemoglobin =9 g/dl, platelets = 100x10(9)/l, hepatic albumin =30 g/l, serum bilirubin =1.5x the upper limit of normal [ULN], AST and ALT =2.5×ULN, ALP =2.5×ULN, TBIL =1.5×ULN, renal serum creatinine <1.5xULN)
- •7. Adequate lung and heart function, without ECG-confirmed ischemic change or ventricular arrhythmias
排除标准
- •1. Serious comorbidities
- •2. Distant metastasis
- •3. Acute inflammation
- •4. Systematic steroid therapy
- •5. Pregnant or breast-feeding women or women considering pregnancy
- •6. Nervous system disorder or psychiatric disease
- •7. Medical history of allergy or hypersensitivity to any drugs
- •8. Patient refusal
研究者
相似试验
已完成
2 期
Efficacy and safety of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for Stage III colon cancer.Colon cancerJPRN-UMIN000012618Kyushu Study group of Clinical Cancer(KSCC)85
终止
3 期
Adjuvant Chemotherapy With S-1 Plus Oxaliplatin Versus S-1 Alone in Locally Advanced Gastric CancerGastric CancerNCT02867839Peking University Cancer Hospital & Institute29
Unknown
1 期
SOX as Adjuvant Chemotherapy for Resectable Gastric CancerGastric CancerNCT01542294Chinese Academy of Medical Sciences71
已完成
2 期
Phase II study of S-1 plus oxaliplatin (130 mg/m2, every 3 weeks) for advanced gastric cancerJPRN-UMIN000016973Shizuoka Cancer Center25
Unknown
1 期
Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant SettingRectal CarcinomaNCT01227239Japan Clinical Cancer Research Organization45