Study of Oxaliplatin, Irinotecan, and S-1 in Biliary Tract Cancer
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Biliary Tract Neoplasm||Drug: Oxaliplatin, Irinotecan, S-1||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Drug: Oxaliplatin, Irinotecan, S-1
Treatment will be delivered every 2 weeks
Other Name: Liplatin, Inotecan, TS-1(tegafur, gimeracil, oteracil)
- 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
- 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
- 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
- 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
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): NCT02527824
|Korea, Republic of|
|Hallym university medical center|
|Anyang, Gyunggi, Korea, Republic of|
|Principal Investigator:||Dae Young Zang, MD, PhD||Hallym University Medical Center|