XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy
NCT ID: NCT02350686
Last Updated: 2019-05-20
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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UNKNOWN
PHASE2
67 participants
INTERVENTIONAL
2015-05-14
2020-12-31
Brief Summary
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Detailed Description
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* Xeloda, 1000mg/㎡ bid, day 1-15, every 3 weeks
* Oxaliplatin 130mg/㎡, day 1, every 3 weeks Until disease progression, patient's refusal or up to 8 cycles (maximum).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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capecitabine+oxaliplatin
XELOX every 3 weeks
capecitabine
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
oxaliplatin
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Interventions
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capecitabine
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
oxaliplatin
XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. histologically or cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, extrahepatic cholangiocarcinoma, gall bladder cancer and ampulla of Vater cancer)
3. unresectable or metastatic
4. progression after treatment with first line gemcitabine-based chemotherapy
5. ECOG performance status of 0\~2
6. measurable or evaluable lesion per RECIST 1.1 criteria
7. adequate marrow, hepatic, renal and cardiac functions
Exclusion Criteria
2. pregnant or lactating women
3. History of documented congestive heart failure, angina pectoris requiring medication, evidence of tranasmural myocardial infarction on ECG, poorly controlled hypertension, clinically significant valvular heart disease or high risk of uncontrollable arrhythmia
4. active CNS metastases not controllable with radiotherapy or corticosteroids
5. known history of hypersensitivity to study drugs
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Ho Yeong Lim
MD, PhD, Division of Hematology-Oncology, Department of Medicine
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2014-09-020
Identifier Type: -
Identifier Source: org_study_id
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