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

• ClinicalTrials.gov Identifier: NCT02570529
• Recruitment Status: Withdrawn
• First Posted: October 7, 2015
• Last Update Posted: January 29, 2019
• Sponsor: Yonsei University
• Information provided by (Responsible Party): Yonsei University

Tracking Information

• First Submitted Date: October 5, 2015
• First Posted Date: October 7, 2015
• Last Update Posted Date: January 29, 2019
• Study Start Date: October 2015
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 6, 2015)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: October 6, 2015): Adverse event of gastrointestinal hemorrhage [ Time Frame: within 4 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevention of Upper Gastrointestinal Hemorrhage Using Albis® in the Patients of Locally Advanced Pancreatic Cancer Who Underwent Concurrent Chemoradiotherapy
• Official Title: Not Provided
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pancreatic Ductal Adenocarcinoma

Intervention

• 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.
• 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.

Study Arms

• Experimental: Albis®
  The intervention group
  Intervention: Drug: Albis®
• Placebo Comparator: Placebo
  The placebo comparator group
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: January 25, 2019): 0
• Original Estimated Enrollment (submitted: October 6, 2015): 78
• Estimated Study Completion Date: February 2018
• Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02570529
• Other Study ID Numbers: 4-2015-0679
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Yonsei University
• Study Sponsor: Yonsei University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Yonsei University
• Verification Date: January 2019