NCT01193452Unknown2 期
A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.
详细描述
This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Oral medication is acceptable
- •Histologically confirmed colorectal carcinoma
- •Male or female ≥ 65 years of age
- •No prior chemotherapy,radiotherapy,target therapy and immunotherapy, except adjuvant chemotherapy with an interval of ≥ 180 days)
- •Presence of at least one target lesion measurable by CT scan or MRI,within 15 days prior to trial
- •The lab values within 2 weeks prior to trial should meet:
- •PLT ≥7.5*10^4/mm3 ANC≥2000/mm3 HB≥100g/L Total bilirubin < upper limit of normal level ALT/AST/ALP < 2.5 x UNL (<5 x UNL for patients with liver or bone metastasis) Serum creatinine < UNL
- •Performance status (ECOG) 0~1
- •Life expectation longer than 90 days
排除标准
- •Allergy to S-1,fluorouracil or leucovorin
- •Any investigational agent(s) within 4 weeks prior to entry
- •Previous or currently exposure to certain drugs which are proved to have influence on blood drug concentration
- •Active infection
- •Severe organ failures or diseases, including: intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes mellitus,clinically relevant coronary disease, cardiovascular disorder or myocardial infarction,renal or liver failure, severe psychiatric illness,cerebral vascular disease and sever GI ulcer which need blood infusion.
- •Uncontrolled hydrothorax,ascites and hydropericardium
- •Multiple bone metastatic lesions
- •Brain metastases
- •Chronic diarrhea or digestive disfunction
- •Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- •Strong willingness to receive surgery or highly potential to have intestinal obstruction which may need surgery intervention
- •Other conditions that primary investigate or investigator consider to be unsuitable for the trial
研究组 & 干预措施
S-1/LV
Experimental
S-1 combined with Leucovorin
干预措施: S-1, Leucovorin (Drug)
sLV5FU2
Active Comparator
5-FU/LV infusion
干预措施: leucovorin, 5-fluorouracil (Drug)
结局指标
主要结局
response rate
时间窗: six weeks
次要结局
- disease control rate(six weeks)
- time to treatment failure(six weeks)
- overall survival(three months)
- quality of life(six weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(six weeks)
- progression free survival(six weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Study of S-1 Plus LV for Advanced Gastric CancerGastric CancerNCT02090153Sun Yat-sen University39
未知
2 期
A Randomized Phase II Study of S-1 plus Leucovorin versus S-1 alone in Patients with Gemcitabine-Refractory Advanced Pancreatic Cancer.Pancreatic cancerJPRN-jRCT2080221515Taiho Pharmaceutical Co., Ltd.140
已完成
2 期
Study of S-1 Plus LV for Untreated Metastatic Colorectal CancerColorectal CancerNCT00891332Taiho Pharmaceutical Co., Ltd.73
Unknown
2 期
Study of S-1 as Second Line Treatment on Advanced Pancreatic CancersPancreatic CancerNCT01074996The Affiliated Hospital of the Chinese Academy of Military Medical Sciences92
已完成
2 期
Phase II study of oral S-1 plus oral leucovorin in patients with previously treated non-small-cell lung cancerPre-treated non-small cell lung cancerJPRN-UMIN000004568Protocol team for S-1 with leucovorin therapy32