- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02527824
Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer
Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Gyunggi
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Anyang, Gyunggi, Korea, Republic of
- Hallym University Medical Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Treatment will be delivered every 2 weeks
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1.5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1.5 year
|
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
|
1.5 year
|
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
|
1.5 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Digestive System Neoplasms
- Biliary Tract Diseases
- Biliary Tract Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Oxaliplatin
- Irinotecan
- Tegafur
Other Study ID Numbers
- HMC-HO-GI-1501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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