NCT01412294Unknown2 期
Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS)
Epidemiological and Clinical Research Information Network1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年7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
- 40
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.
详细描述
S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Weeks 至 74 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent gastric cancer histologically confirmed as being adenocarcinoma
- •Age of 20 to 74 years with either gender
- •ECOG Performance Status of 0 to 2
- •Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
- •Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period
- •Less than 6 months treatment-free interval from completion of adjuvant therapy
- •In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2
- •Treatment-naïve recurrent gastric cancer
- •Life expectancy of at least 3 months after registration
- •Written informed consent
- •Adequate major organ functions within 14 days before registration
排除标准
- •Positive HER2 status
- •Previous treatment with platinum agents after curative surgery
- •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
- •Concurrent illness 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 phenytoin or warfarin potassium
- •Chronic diarrhea (watery stool or ≥ 4 times/day)
- •Active gastrointestinal hemorrhage
- •Body cavity fluids requiring drainage or other treatment
- •Clinical suspicion or previous history of metastases to brain or meninges
- •Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) 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
Capecitabine, Cisplatin
Experimental
干预措施: Capecitabine, Cisplatin (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 year
次要结局
- Overall survival(2 year)
- Response rate(2 year)
- Time to treatment failure(2 year)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(2 year)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Capecitabine as NeoAdjuvant Therapy in Locally Advanced Breast CancerBreast CancerNCT00347438University of Chicago18
已完成
2 期
Capecitabine and Thalidomide in Previously Treated Metastatic Colorectal CarcinomaColorectal AdenocarcinomaNCT00165217Dana-Farber Cancer Institute37
已完成
2 期
Capecitabine, Gemcitabine, and Bevacizumab in Combination for Patients With Sarcomatoid Renal Cell CarcinomaKidney CancerRenal Cell CarcinomaNCT00496587M.D. Anderson Cancer Center34
Unknown
2 期
Phase II Study With Cabozantinib in Patients With RET Positive NSCLCNon Small Cell Lung CancerNCT04131543University of Bologna25
已完成
2 期
Safety and Efficacy Study to Compare Capecitabine + Bevacizumab Versus Capecitabine, Concomitantly With Radiotherapy as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal CancerRectal CancerNCT01043484Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)90