JPRN-jRCTs051180086已完成2 期
A phase II study of preoperative chemotherapy cosisting docetaxel, oxaliplatin and S-1 for the clinical Stage III gastric cancer - A phase II study of preoperative DOS for cStage III gastric cancer
Kurokawa Yukinori0 个研究点目标入组 50 人开始时间: 2019年3月4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
- 50
研究概览
简要总结
The primary endpoint, the 3-year progression-free survival rate, was 54.2% (80% CI, 52.2%-70.8%; 95% CI, 41.8%-70.3%), and the lower limit of the 80% confidence interval exceeded the 50% threshold. This showed a statistically significant difference. There were no major safety issues, and preoperative DOS therapy was considered to be a promising treatment regimen for cStage III gastric cancer and esophagogastric junction cancer.
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 adenocarcinoma.
- •2) cStage III gastric or esophagogastric junction cancer.
- •3) Not Borrmann type 4 and not large (8cm or less) type 3.
- •4) Possible for R0 surgery.
- •5) No prior treatment of chemotherapy or radiation therapy and no history of surgery for gastric cancer.
- •6) No active gastrointestinal bleeding.
- •7) Possible oral intake or administration of adequate calories using an enteral feeding tube.
- •8) ECOG performance status of 0 or 1.
- •9) Aged 20 to 79 years old.
- •10) No prior treatment of chemotherapy, radiation or hormone therapy against any other malignancies.
- •11) No history of gastrectomy other than endoscopic mucosal resection.
- •12) Adequate organ function.
- •13) 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) Active infection.
- •4) Severe complications (interstitial pneumonia, pulmonary fibrosis, renal failure, liver failure, heart failure, uncontrollable diabetes millutus and Uncontrollable hypertension)
- •5) Peripheral motor neuropathy or peripheral sensory neuropathy by any reason.
- •6) Edema of limbs and trunk by any reason.
- •7) Continuous systemic steroid therapy.
- •8) Under treatment with flucytosine, phenytoin, or warfarin.
- •9) Abnormal electrocardiogram or severe cardiovascular disease.
- •10) Severe diarrhea.
- •11) Positive HBs antigen.
- •12) Pregnant women, or women with the possibility of the pregnancy and men who want let to pregnancy.
研究者
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