Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 3:53 PM
Ignite Modification Date: 2025-12-24 @ 3:53 PM
NCT ID: NCT00504192
Brief Summary: The role of systemic chemotherapy in advanced biliary tract cancer (BTC) is known to be very limited although various single-agent or combination therapies had been tested. However, there is a possibility that palliative chemotherapy induce prolong survival and improve quality of life in advanced BTC based on several studies. A GERCOR study showed the promising result of gemcitabine in combination with oxaliplatin as first line chemotherapy in advanced BTC. Therefore, this phase II trial was planned to investigate efficacy and toxicity of combination chemotherapy with gemcitabine and dose adjusted oxaliplatin in patients with inoperable BTC in Korea.
Detailed Description: Treatment scheme :Gemcitabine 1000 mg/m2/d IV D1 as a 10mg/m2/min Oxaliplatin 85 mg/m2/d IV D2 as a 2 hours infusion Each cycle is repeated every 2 weeks. Repeated cycles of treatment will be given for this study unless there is confirmed disease progression or unacceptable toxicity. Subjects will be treated for at least 4 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent.
Study: NCT00504192
Study Brief:
Protocol Section: NCT00504192