JPRN-jRCTs051180109已完成2 期
Perioperative capecitabine plus oxaliplatin therapy for clinical stage III gastric cancer: a phase II study, OGSG1601 - Perioperative capecitabine plus oxaliplatin therapy for clinical stage III gastric cancer: a phase II study, OGSG1601
GOTO Masahiro0 个研究点目标入组 37 人开始时间: 2019年3月8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
- 37
研究概览
简要总结
Perioperative CapeOx showed good feasibility and favorable efficacy with sufficient pathological response, although statistical significance at 0.058 did not reach the commonly accepted cutoff of 0.05. The data obtained using this novel approach warrant further investigations.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Histological proven adenocarcinoma.
- •2) cSS/SE N1-3 M0 gastric cancer.
- •3) Possible oral intake
- •4) ECOG performance status of 0 or 1.
- •5) Aged 20 years old or over.
- •6) Adequate organ function
- •7)Written informed consent from patient.
排除标准
- •1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
- •2) Past history of severe hypersensitivity to drugs.
- •3) with active infection (a fever over 38 degrees)
- •4) Pregnant women, or women with the possibility of the pregnancy
- •5) Men who want let to pregnancy.
- •6) History of myocardial infarction with 6 months
- •7) Continuous systemic steroid therapy
- •8) Under treatment with flucytosine, phenytoin.
- •9) Severe diarrhea
- •10) Positive HBs antigen
- •11) Severe complications
- •12) Bulky lymph node metastasis, Borrmann type 4 or large (8cm or less) type 3.
- •13) Patients judged inappropriate for the study by the physicians.
研究者
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