Prevention of Upper Gastrointestinal Hemorrhage Using Albis® in the Patients of Locally Advanced Pancreatic Cancer Who Underwent Concurrent Chemoradiotherapy

Phase 4

Withdrawn

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Albis®	Albis®	The intervention group
Placebo	Placebo	The placebo comparator group

Primary Outcome Measures

Name	Time	Method
Gastrointestinal ulcer incidence	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

Secondary Outcome Measures

Name	Time	Method
Adverse event of gastrointestinal hemorrhage	within 4 weeks

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