JPRN-jRCTs041180052已完成2 期
Feasibility study of adjuvant chemotherapy of S-1/Oxaliplatin for patients with Stage III gastric cancer patients - SOX-GC
Kamiya Kinji0 个研究点目标入组 16 人开始时间: 2019年2月26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
- 16
研究概览
简要总结
S-1/oxaliplatin regimen as adjuvant chemotherapy after D2 gastrectomy in stage III gastric cancer treatment seems feasible for outpatients with tolerable toxicities.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •1) Histological proven gastric cancer
- •2) Surgical operated by D2 lymphadenectomy and curability A
- •3) Clinical Stage IIIA, IIIB, IIIC (T2N3, T3N2-3, T4aN1-3, T4bN0-3) according to Japanese Classification of Gastric Cancer 14th edition
- •4) Age 20-80 years
- •5) No pretreatment (radiotherapy, chemotherapy, hormone therapy etc.) except surgery
- •6) Capable of protocol therapy within 56 days after gastrectomy
- •7) PS (ECOG) 0 or 1
- •8) Capable oral food uptake
- •9) Clear to the criteria as below within 14days after registration
- •-Hemoglobin: > 9.0 g/dL
- •-Leukocyte: > 3,000 /mm3 < 12,000 /mm3
- •-Neutrophil: > 1,500 /mm3
- •-Blood platelet count: > 100,000 /mm3
- •-Total bilirubin: < 1.5 mg/dL
- •-AST (GOT), ALT (GPT): < 100 IU/L
- •-Creatinine clearance: > 60 mL/min
- •10) Capable to have given written informed consent to participate in this study
排除标准
- •1) Active synchronous metachronous malignancy with longer than 5year interval period without below written cases
- •-Carcinoma in situ of cervical cancer and focal cancer in adenoma of colorectal cancer
- •2) Contraindication of S-1 and Oxaliplatin
- •3) Regular use of flucytosine, phenytoin or warfarin potassium
- •4) Active infection with over 38 degree fever
- •5) History of serious drug hypersensitivity
- •6) Any other serious illness or medical conditions including interstitial paresis, intestinal obstruction, pneumonitis, pulmonary fibrosis, uncontrolled diabetes, renal failure, liver failure
- •7) HIV positive or active hepatitis
- •8) Severe diarrhea (over 4 times/day or watery diarrhea)
- •9) Pregnancy or lactation
- •10) Male intension that get with child
- •11) Patients who are recognized as inadequate patients by doctor with responsibility in this study
研究者
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