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

Yonsei University

Status and phase

Withdrawn

Phase 4

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Drug: Albis®

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02570529

4-2015-0679

Details and patient eligibility

About

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.

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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