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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486497
• Other study ID #: SNUBH-IMGPB-2015-01
• Status: Completed
• Phase: N/A
• First received: June 23, 2015
• Last updated: September 21, 2017
• Start date: June 2015
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence free survival		Upto 24 weeks
Secondary	Overall survival		Upto 24 weeks
Secondary	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