Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining
1 other identifier
interventional
40
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pancreatic-cancer
Started Jun 2015
Shorter than P25 for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedSeptember 25, 2017
August 1, 2016
1.9 years
June 23, 2015
September 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence free survival
Upto 24 weeks
Secondary Outcomes (2)
Overall survival
Upto 24 weeks
Toxicity
Upto 24 weeks
Study Arms (2)
5-FU group
ACTIVE COMPARATORGrades of hENT1 immunostaining are 0 or 1.
Gemcitabine group
ACTIVE COMPARATORGrade of hENT1 immunostaining is 2.
Interventions
hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- IlDong Pharmaceutical Co Ltdcollaborator
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
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.
PMID: 33795193DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2015
First Posted
July 1, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
September 25, 2017
Record last verified: 2016-08