NCT01406249Unknown2 期
A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)
Epidemiological and Clinical Research Information Network1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival rate
研究概览
简要总结
The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.
详细描述
XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
- •Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
- •No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
- •ECOG Performance Status of 0 to 2
- •Life expectancy of at least 3 months after registration
- •Written informed consent
- •Age of 20 to 74 years with either gender
- •Adequate Major organ functions within 14 days before registration
排除标准
- •Positive HER2 status
- •Previous history of fluoropyrimidines therapy within 6 months prior to registration
- •Previous treatment with platinum agents
- •Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
- •Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
- •More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
- •Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
- •Active hepatitis
- •Heart disease that is serious or requires hospitalization, or history of such disease within past year
- •Having complication that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)
- •Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
- •Chronic diarrhea (watery stool or ≥4 times/day)
- •Active gastrointestinal bleeding
- •Body cavity fluids requiring drainage or other treatment
- •Clinical suspicion or previous history of metastasis to brain or meninges
- •Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
- •Unwillingness to practice contraception
- •Poor oral intake
- •Psychiatric disorders which are being or may need to be treated with psychotropics
- •Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
研究组 & 干预措施
S-1,Cisplatin
Active Comparator
干预措施: SP (Drug)
Capecitabine, Cisplatin
Experimental
干预措施: XP (Drug)
结局指标
主要结局
Progression-free survival rate
时间窗: at 24weeks from patient enrollment
次要结局
- Overall survival(3 year)
- Time-to treatment failure(3year)
- Response rate(3 year)
- Safety(3 year)
研究者
研究点 (1)
Loading locations...
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