Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2010-04-30
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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5-fluorouracil, leucovorin, oxaliplatin
D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed adenocarcinoma of the biliary tract
3. Metastatic or unresectable biliary cancer
4. Prior exposure to gemcitabine chemotherapy for biliary cancer
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
6. 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
7. Adequate bone marrow, liver, renal function
Exclusion Criteria
2. Other serious illness or medical condition, notably heart or lung failure, active uncontrolled infection (infection requiring antibiotics).
3. Past or concurrent history of other neoplasm, except curatively treated basal cell skin cancer or adequately treated in-situ carcinoma of the cervix.
4. Symptomatic or uncontrolled brain metastasis
18 Years
ALL
No
Sponsors
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Gyeongsang National University Hospital
OTHER
Dong-A University Hospital
OTHER
Samsung Medical Center
OTHER
Chung-Ang University
OTHER
Responsible Party
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In Gyu Hwang
Chung-Ang University Hospital
Principal Investigators
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In Gyu Hwang, M.D.
Role: STUDY_DIRECTOR
Chung-Ang University Yongsan Hospital
Locations
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Chung-Ang University Yongsan Hospital
Yongsan, Seoul, South Korea
Countries
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Other Identifiers
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CAUHHO 2010-2
Identifier Type: -
Identifier Source: org_study_id