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Trial record 37 of 131 for:    Pancreatic Cancer | ( Map: South Korea )

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

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ClinicalTrials.gov Identifier: NCT02486497
Recruitment Status : Completed
First Posted : July 1, 2015
Last Update Posted : September 25, 2017
Sponsor:
Collaborator:
IlDong Pharmaceutical Co Ltd
Information provided by (Responsible Party):
Seoul National University Hospital

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).

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: hENT1 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Gemcitabine Versus 5-FU/Leucovorin Based on hENT1 Immunostaining After Curative Surgery of Pancreatic Cancer
Study Start Date : June 2015
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017


Arm Intervention/treatment
Active Comparator: 5-FU group
Grades of hENT1 immunostaining are 0 or 1.
Biological: hENT1
hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.

Active Comparator: Gemcitabine group
Grade of hENT1 immunostaining is 2.
Biological: hENT1
hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.




Primary Outcome Measures :
  1. Recurrence free survival [ Time Frame: Upto 24 weeks ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02486497


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
IlDong Pharmaceutical Co Ltd

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02486497     History of Changes
Other Study ID Numbers: SNUBH-IMGPB-2015-01
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: August 2016
Keywords provided by Seoul National University Hospital:
Pancreatic cancer
Adjuvant chemotherapy
hENT1
Gemcitabine
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs