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

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Albis®

Placebo

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic cancer, Chemoradiotherapy, Gastrointestinal toxicity, Albis

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Albis®

Placebo

Arm Description

The intervention group

The placebo comparator group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse event of gastrointestinal hemorrhage

Full Information

NCT ID

NCT02570529

First Posted

October 5, 2015

Last Updated

January 25, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT02570529

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Withdrawn

Why Stopped

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

Study Start Date

October 2015 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic cancer, Chemoradiotherapy, Gastrointestinal toxicity, Albis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Albis®

Arm Type

Experimental

Arm Description

The intervention group

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The placebo comparator group

Intervention Type

Drug

Intervention Name(s)

Albis®

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Gastrointestinal ulcer incidence

Description

Time Frame

within 4 weeks from end of chemoradiation

Secondary Outcome Measure Information:

Title

Adverse event of gastrointestinal hemorrhage

Time Frame

within 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

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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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