Status:
UNKNOWN
Study of GEMOX(Gemcitabine/Oxaliplatin) Versus XELOX(Xeloda/Oxaliplatin) in Advanced Biliary Tract Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Biliary Tract (Intrahepatic, Extrahepatic Cholangiocarcinoma, Gall Bladder) Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of the trial is to compare Progression free survival between GEMOX (gemcitabine/oxaliplatin)vs XELOX(capecitabine/oxaliplatin)in metastatic or unresectable Biliary tract carcinoma patien...
Detailed Description
In patients with advanced BTC(biliary tract cancer), either gemcitabine-based, 5-FU-based chemotherapy or clinical trial is recommended as first-line treatment. According to ABC-02 trial, as compared ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- age ≥ 18
- histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer.however, ampulla of vater cancer is excluded)
- unresectable or metastatic
- ECOG performance status of 0\~2
- measurable or evaluable lesion per RECIST 1.1 criteria
- Life expectancy≥12weeks
- Adequate marrow, hepatic, renal and cardiac functions Serum aspartate transaminase and serum alanine transaminase≤ 2.5 x upper limit of normal (ULN), or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy Total serum bilirubin ≤ 1.5 x ULN Absolute neutrophil count(ANC) ≥ 1,500/uL Platelets ≥ 100,0000/uL Hemoglobin ≥ 8.0 g/dL
- chemotherapy naïve patient: prior adjuvant chemoradiation or chemotherapy is allowed if the last date of drug administration is \> 6 months from the study entry date
- provision of a signed written informed consent
- Exclusion criteria
- severe co-morbid illness and/or active infections
- ampulla of vater cancer is excluded
- pregnant or lactating women
- Active CNS metastases not controllable with radiotherapy or corticosteroids (however,CNS metastases(except for leptomeningeal seeding) are allowed if controlled by gamma knife surgery or surgery or radiotherapy or steroid)
- known history of hypersensitivity to study drugs
Exclusion
Key Trial Info
Start Date :
December 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01470443
Start Date
December 28 2011
End Date
December 1 2020
Last Update
May 21 2019
Active Locations (1)
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1
Samsung medical Center
Seoul, South Korea, 135-710