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Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02527824
Recruitment Status : Unknown
Verified August 2017 by Hallym University Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2015
Last Update Posted : August 23, 2017
Jeil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Hallym University Medical Center

Brief Summary:
This study will conduct a phase II study of triple combination with oxaliplatin, irinotecan, and S-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasm Drug: Oxaliplatin, Irinotecan, S-1 Phase 2

Detailed Description:

It is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. In general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy.

S-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. So the investigators had conducted the phase I study of three drugs (oxaliplatin, irinotecan, and S-1) with modification of dosage and schedule and will conduct a phase II study with recommended dose of triple chemotherapy from this phase I study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
Study Start Date : March 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: Oxaliplatin, Irinotecan, S-1(OIS)

intervention with triple combination chemotherapy with oxaliplatin, irinotecan, and S-1 Treatment will be delivered as a 2-week cycle.

  1. Oxaliplatin 65 mg/m2 iv on day 1
  2. Irinotecan 135 mg/m2 iv on day 1
  3. S-1 80 mg/m2/day on day 1-7
Drug: Oxaliplatin, Irinotecan, S-1

Treatment will be delivered every 2 weeks

  1. Oxaliplatin 65 mg/m2 iv on day 1
  2. Irinotecan 135 mg/m2 iv on day 1
  3. S-1 80 mg/m2/day on day1-7
Other Name: Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)

Primary Outcome Measures :
  1. overall response rate [ Time Frame: 1.5 year ]
    Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 1.5 year ]
    The progression-free survival (PFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause

  2. overall survival [ Time Frame: 1.5 year ]
    The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method

  3. toxicity profiles - the number of participants and grade of intensity of treatment related adverse events [ Time Frame: 1.5 year ]
    adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 4.0

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage IV by primary tumor, regional nodes, metastasis(TNM) staging system)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • More than 3 months expected life span
  • Measurable lesion by RECIST criteria version 1.1
  • Palliative chemotherapy naive
  • Adequate organ functions
  • Participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital

Exclusion Criteria:

  • Any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer.
  • Participants who had received radiation therapy for target lesions 4 weeks before study enrollment
  • Participants who had received major surgery 4 weeks before study enrollment
  • Participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding
  • Participants with central nervous system(CNS) metastases
  • Participants with peripheral sensory neuropathies with impaired functional activities
  • Participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.

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 identifier (NCT number): NCT02527824

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Korea, Republic of
Hallym university medical center
Anyang, Gyunggi, Korea, Republic of
Sponsors and Collaborators
Hallym University Medical Center
Jeil Pharmaceutical Co., Ltd.
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Principal Investigator: Dae Young Zang, MD, PhD Hallym University Medical Center

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Responsible Party: Hallym University Medical Center Identifier: NCT02527824     History of Changes
Other Study ID Numbers: HMC-HO-GI-1501
First Posted: August 19, 2015    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hallym University Medical Center:
biliary tract neoplasm
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action