Prevention of Upper Gastrointestinal Hemorrhage Using Albis® in the Patients of Locally Advanced Pancreatic Cancer Who Underwent Concurrent Chemoradiotherapy
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Gastrointestinal ulcer incidence
研究概览
简要总结
Pancreatic ductal adenocarcinoma is the fourth cause of death in the Western world. About 40% of pancreatic cancer patients were diagnosed as locally advanced unresectable status without distant metastasis. Concurrent chemoradiotherapy (CCRT) was a reasonable treatment modality for locally advanced pancreatic cancer. However, several adverse events of chemoradiation could lead unfavorable treatment results, which included unique gastrointestinal (GI) toxicities, such as ulcer and hemorrhage in the stomach and duodenum that are included in the radiation field. According to the study in the investigators hospital, 45% of locally advanced pancreatic cancer patients treated with CCRT suffered from GI ulcers, and among them, 65% of the patients experienced the significant hemorrhage events. Although these GI toxicities, the studies for radioprotective agents were limited. Albis® is a newly developed drug comprised of ranitidine, bismuth and sucralfate. The investigators will investigate the radioprotective effect of Albis® for locally advanced pancreatic cancer patients treated with CCRT.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 20 years old and younger than 80 years old
- •Pathologically confirmed pancreatic ductal adenocarcinoma (metastatic or locally advanced stage)
- •ECOG Performance status ≤2
- •Scheduled fot concurrent chemoradiation
- •Adequate liver function (total bilirubin < 1.5 X the upper limits of normal (ULN), AST and ALT <3 X UNL, and alkaline phosphatases < 3 X ULN or < 5 x ULN in case of liver involvement)
- •Adequate BM function (WBC ≥ 3,500/µl, absolute neutrophil cell count ≥ 1,500 /µl, platelet count ≥ 100,000/µl)
- •Not remarkable coagulation profile (PT < 1.5 international normalized ratio(INR), aPTT <35 sec)
- •Subjects who given written informed consent after being given a full description of the study
排除标准
- •Coexisting of other malignancies within 5 years, except squamous cell carcinoma and basal cell carcinoma of the skin
- •Evidence of distant metastasis, such as liver, peritoneum and brain
- •history of receiving the chemoradiation for pancreatic cancer in the other hospital
- •History of receiving the operation which affect the anatomy of upper gastrointestinal tract
- •Any trouble for examination of upper endoscopy
- •Evidence of GI ulcers (A1~H2) on endoscopy before start of chemoradiotherapy.
- •Use of aspirin, anti-platelet agent, anticoagulation agent, NSAIDs, or glucocorticoid within 1 week or enable to stop the administration (including start during chemoradiation)
- •Use of PPI, Histamine-2 receptor antagonist, antacid, prostaglandin, sucralfate within 2 weeks or enable to stop the administration
- •Patients who are unwilling or unable to provide informed consent, such as those with psychiatric problem, drug abuse or alcoholism
研究组 & 干预措施
Albis®
The intervention group
干预措施: Albis® (Drug)
Placebo
The placebo comparator group
干预措施: Placebo (Drug)
结局指标
主要结局
Gastrointestinal ulcer incidence
时间窗: within 4 weeks from end of chemoradiation
After 1 month after the chemoradiation, all the patients receive the esophagogastroduodenoscopy to detect the development of gastrointestinal ulcers. The proportion of patients with radiation-induced GI ulcers in each group will be investigated
次要结局
- Adverse event of gastrointestinal hemorrhage(within 4 weeks)