Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining
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About
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).
Full 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.
Enrollment
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Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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