Terminated PHASE2 INTERVENTIONAL 2-arm NCT01096745

Randomized Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer

Randomized Phase II Trial of Gemcitabine/Cisplatin Versus S-1/Cisplatin in Advanced Biliary Cancer Patients

Sponsor: Chung-Ang University

Conditions Locally Advanced Biliary Tract Cancer Metastatic Biliary Tract Cancer

Interventions Gemcitabine, Cisplatin S-1, Cisplatin

Updated 6 times since 2017 Last updated: Jun 21, 2011 Started: Jul 31, 2010 Primary completion: Mar 31, 2013 Completion: Sep 30, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Planning for randomized phase III trial for this issue.

Listed as NCT01096745, this PHASE2 trial focuses on Locally Advanced Biliary Tract Cancer and Metastatic Biliary Tract Cancer and remains terminated or withdrawn. Sponsored by Chung-Ang University, it has been updated 6 times since 2010, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field. Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Standard chemotherapy regimen for biliary tract cancer(BTC) has not been established due to the difficulty associated with performing clinical trials in this field.

Gemcitabine or fluoropyrimidines, including 5-fluorouracil and S-1, are routinely used for BTC chemotherapy. The European Society for Medical Oncology (ESMO) and the National Comprehensive Cancer Network guidelines published in 2009 recommend either gemcitabine-based or fluoropyrimidine-based chemotherapy or clinical trials for first-line treatment.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE2
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE2
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE2
Jan 2021 — Jul 2024 [monthly]

Terminated PHASE2
Jun 2018 — Jan 2021 [monthly]

Terminated PHASE2

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Terminated PHASE2

First recorded

Jul 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Chung-Ang University
Dong-A University
Gyeongsang National University Hospital
Samsung Medical Center

Data source: Gyeongsang National University Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Jinju, South Korea