Pancreatic Cancer
Conditions
Keywords
Pancreatic cancer, Adjuvant chemotherapy, hENT1, Gemcitabine
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.
Interventions
BIOLOGICALhENT1
hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.
Sponsors
IlDong Pharmaceutical Co Ltd
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence free survival | Upto 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed