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

NCT02570529 | Withdrawn Phase 4

• 1 other identifier: 4-2015-0679
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic cancer; Chemoradiotherapy; Gastrointestinal toxicity; Albis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse event of gastrointestinal hemorrhage

  within 4 weeks

Study Arms (2)

Albis®

EXPERIMENTAL

The intervention group

Drug: Albis®

Placebo

PLACEBO COMPARATOR

The placebo comparator group

Drug: Placebo

Interventions

Albis® DRUG

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.

Albis®

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: February 1, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01