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

NCT ID: NCT02570529

Last Updated: 2019-01-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Albis®

The intervention group

Group Type: EXPERIMENTAL

Albis®

Intervention Type: 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.

Placebo

The placebo comparator group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

4-2015-0679

Identifier Type: -

Identifier Source: org_study_id