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NCT Number: NCT02486497

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

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).

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hENT1

Biological

hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.

Primary outcomes

  1. Recurrence free survival

    Time frame: Upto 24 weeks

Secondary outcomes

  1. Overall survival

    Time frame: Upto 24 weeks

  2. Toxicity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • IlDong Pharmaceutical Co Ltd

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 1, 2015
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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