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

Conditions

• Biliary Tract Neoplasm

Eligibility Criteria

Sex

ALL

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Oxaliplatin, Irinotecan, S-1 — DRUG
  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

Study Details

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.

Key Dates

Start date

Mar 31, 2015

Status verified

Aug 2017

Primary completion

Aug 31, 2016

Completion

Sep 30, 2017

Study Design

Enrollment

31 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

overall response rate [ Time Frame: 1.5 year ]