WithdrawnPhase 4

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

Stopped: Investigator decided to stop the study because it was difficult to proceed with the study.

0Started 2015-10

Plain-language 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.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gastrointestinal ulcer incidence

Timeframe: within 4 weeks from end of chemoradiation

Trial details

NCT IDNCT02570529

SponsorYonsei University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-10

View on ClinicalTrials.gov More Pancreatic Ductal Adenocarcinoma trials