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

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ClinicalTrials.gov Identifier: NCT02570529
Recruitment Status : Withdrawn (Investigator decided to stop the study because it was difficult to proceed with the study.)
First Posted : October 7, 2015
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Drug: Albis® Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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 radiation, they receive the 1 month's medication.

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 radiation, they receive the 1 month's medication.




Primary Outcome Measures :
  1. Gastrointestinal ulcer incidence [ Time Frame: 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 :
  1. Adverse event of gastrointestinal hemorrhage [ Time Frame: within 4 weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02570529    
Other Study ID Numbers: 4-2015-0679
First Posted: October 7, 2015    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Keywords provided by Yonsei University:
Pancreatic cancer
Chemoradiotherapy
Gastrointestinal toxicity
Albis
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms