NCT02527824

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

1.4 years

First QC Date

August 14, 2015

Last Update Submit

August 22, 2017

Conditions

Biliary Tract Neoplasm

Keywords

biliary tract neoplasmoxaliplatinirinotecanS-1

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    Tumor response will be classified on the basis of the response evaluation criteria in solid tumors (RECIST) guidelines version 1.1

    1.5 year

Secondary Outcomes (3)

  • progression free survival

    1.5 year

  • overall survival

    1.5 year

  • toxicity profiles - the number of participants and grade of intensity of treatment related adverse events

    1.5 year

Study Arms (1)

Oxaliplatin, Irinotecan, S-1(OIS)

EXPERIMENTAL

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

Interventions

Oxaliplatin, Irinotecan, S-1DRUG

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

Also known as: Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)
Oxaliplatin, Irinotecan, S-1(OIS)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym university medical center

Anyang, Gyunggi, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

OxaliplatinIrinotecanS 1 (combination)gimeracilOxonic Acid

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsCamptothecinAlkaloidsHeterocyclic CompoundsTriazinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Dae Young Zang, MD, PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2015

First Posted

August 19, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

KR(1)