Salvage mFOLFOX in BTC After Failure of Gemcitabine
Phase 2
Completed
- Conditions
- Unresectable Biliary Tract Cancer
- Registration Number
- NCT01127555
- Lead Sponsor
- Chung-Ang University
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of mFOLFOX (5-fluorouracil, leucovorin, oxaliplatin)as salvage therapy in patients with unresectable biliary tract cancer who had failed gemcitabine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Age : older than 18
- Histologically confirmed adenocarcinoma of the biliary tract
- Metastatic or unresectable biliary cancer
- Prior exposure to gemcitabine chemotherapy for biliary cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in spiral Computed Tomography (CT) or multidetector CT
- Adequate bone marrow, liver, renal function
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Exclusion Criteria
- Pregnancy and breast-feeding.
- Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
- Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
- Symptomatic or uncontrolled brain metastasis
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response rate 1 year Clinically assessed every cycle (2weeks) and radiologically assessed every 3 cycles (6 weeks) with CT scan
- Secondary Outcome Measures
Name Time Method To evaluate the safety 1 year Clinically assessed every cycle (2weeks)
To estimate the time to progression 1 year To estimate overall survival 1 year
Trial Locations
- Locations (1)
Chung-Ang University Yongsan Hospital
🇰🇷Yongsan, Seoul, Korea, Republic of