Prevention Of Upper Gastrointestinal Hemorrhage Using Albis® In The Patients Of Locally Advanced Pancreatic Cancer Who Underwent Concurrent Chemoradiotherapy

Study Overview

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

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.

N/A

Pancreatic Ductal Adenocarcinoma

DRUG: Albis®
DRUG: Placebo

4-2015-0679

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-10-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2019-01-25
First Submitted that Met QC Criteria 2015-10-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2019-01-29
First Posted (ACTUAL) 2015-10-07	Results First Posted N/A	Last Verified 2019-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Quadruple

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Albis® The intervention group	DRUG: Albis® The patients take Albis® 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after
PLACEBO_COMPARATOR: Placebo The placebo comparator group	DRUG: Placebo The patients take placebo 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Albis®

The intervention group

DRUG: Albis®

The patients take Albis® 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after

PLACEBO_COMPARATOR: Placebo

The placebo comparator group

DRUG: Placebo

The patients take placebo 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after

Primary Outcome Measures	Measure Description	Time Frame
Gastrointestinal ulcer incidence	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	within 4 weeks from end of chemoradiation

Secondary Outcome Measures	Measure Description	Time Frame
Adverse event of gastrointestinal hemorrhage		within 4 weeks

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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