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
Phase II Study of S-1 in Combination With Oxaliplatin and Irinotecan in Patients With Advanced, Recurrent or Metastatic Biliary Tract Cancer
Sponsor study identifier
interventional
31
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
August 14, 2015
Actual (reported)August 19, 2015
Actual (reported)August 2016
Actual (reported)September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Oxaliplatin, Irinotecan, S-1
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordHallym university medical center
Anyang, Gyunggi, South Korea
Dae Young Zang, MD, PhD
Hallym University Medical Center
First Submitted
August 14, 2015
First Posted
August 19, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)Study of Nivolumab in Combination With Gemcitabine/Cisplatin or Ipilimumab for Patients With Advanced Unresectable Biliary Tract Cancer
Contact the study team to confirm eligibility.
Study Completion
September 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 23, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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