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

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: hENT1

• Registration Number: NCT02486497
• Lead Sponsor: Seoul National University Hospital

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).

Detailed Description

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-28
• Study First Posted: 2015-07-01
• Status Verified: 2016-08
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-09-21
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine group	hENT1	Grade of hENT1 immunostaining is 2.
5-FU group	hENT1	Grades of hENT1 immunostaining are 0 or 1.

Primary Outcome Measures

Name	Time	Method
Recurrence free survival	Upto 24 weeks

Secondary Outcome Measures

Name	Time	Method
Overall survival	Upto 24 weeks
Toxicity	Upto 24 weeks	Hematologic and hepatic toxicity according to blood test results \& non-hematologic toxicity (fatigue, vomiting, diarrhea, sensory neuropathy) according to CTCAE 4.0 scale

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi-do, Korea, Republic of