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Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining

NCT ID: NCT02486497

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-05-31

Brief Summary

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Human equilibrative nucleoside transporter 1 (hENT1) is a membrane transporter which is a predicting marker for gemcitabine chemotherapy. However, there is a limited evidence of it as an indicator for adjuvant gemcitabine chemotherapy. In this study, investigators try to investigate the role of hENT1 as a indicator of selection of adjuvant chemotherapy regimen between gemcitabine and 5-fluorouracil (5-FU).

Detailed Description

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After surgical resection of pancreatic cancer, the tissue is immunostained by hENT1 antibody. The grades of immunostaining are categorized as 0 (0%), 1 (\<50%), and 2 (\>=50%). According to the grade, patients with grade 0 or 1 will be treated with 5-FU and those with grade 2 will be treated with gemcitabine. After the study, investigators will calculate the overall survival and recurrence free survival of the patients and investigate the role of hENT1 as a predictive biomarker for adjuvant gemcitabine chemotherapy.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5-FU group

Grades of hENT1 immunostaining are 0 or 1.

Group Type ACTIVE_COMPARATOR

hENT1

Intervention Type BIOLOGICAL

hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.

Gemcitabine group

Grade of hENT1 immunostaining is 2.

Group Type ACTIVE_COMPARATOR

hENT1

Intervention Type BIOLOGICAL

hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.

Interventions

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hENT1

hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with curatively resected pancreatic cancer
* Age between 18 and 75
* Eastern Cooperative Oncology Group performance score 0 or 1
* Patients with compliance
* Patients with informed consent

Exclusion Criteria

* Patients refuse to enroll this study
* Patients with concomitant chemoradiation therapy
* Previous chemotherapy
* Pregnant or preparing a pregnancy
* Uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarction within 6 months
* Enrolled another clinical trial within 30 days
* Patients will be expected to be risk because of enrollment
* Patients without informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IlDong Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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Shin DW, Lee JC, Kim J, Yoon YS, Han HS, Kim H, Hwang JH. Tailored adjuvant gemcitabine versus 5-fluorouracil/folinic acid based on hENT1 immunohistochemical staining in resected pancreatic ductal adenocarcinoma: A biomarker stratified prospective trial. Pancreatology. 2021 Jun;21(4):796-804. doi: 10.1016/j.pan.2021.02.022. Epub 2021 Mar 4.

Reference Type DERIVED
PMID: 33795193 (View on PubMed)

Other Identifiers

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SNUBH-IMGPB-2015-01

Identifier Type: -

Identifier Source: org_study_id