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

Study Overview
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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.

Official Title
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Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining After Curative Surgery of Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: hENT1


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5-FU group<br>Grades of hENT1 immunostaining are 0 or 1. | Biological: hENT1<br>* hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.<br>|
| Active Comparator: Gemcitabine group<br>Grade of hENT1 immunostaining is 2. | Biological: hENT1<br>* hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival |  | Upto 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | Upto 24 weeks | 
| Toxicity | Hematologic and hepatic toxicity according to blood test results & non-hematologic toxicity (fatigue, vomiting, diarrhea, sensory neuropathy) according to CTCAE 4.0 scale | Upto 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic cancer, Adjuvant chemotherapy, hENT1, Gemcitabine