Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
NCT ID: NCT00868569
Last Updated: 2009-03-25
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
PHASE4
200 participants
INTERVENTIONAL
2008-01-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.
TACE + folfox 4
tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml
folfox4
2
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy (TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
TAC + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
folfox4
Interventions
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TACE + folfox 4
tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml
folfox4
TAC + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
folfox4
Eligibility Criteria
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Inclusion Criteria
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* no prior cancer therapy
* with measurable unresectableliver metastasis
* without other metastasis
Exclusion Criteria
* severe major organ dysfunction
* WHO performance status of \>1
* prior cancer therapy
* with other metastasis
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhongshan hospital, Fudan University
Principal Investigators
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jianmin xu, MD, PHD
Role: STUDY_DIRECTOR
department of general surgery, zhongshan hospital, fudan university
Locations
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Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009-03
Identifier Type: -
Identifier Source: org_study_id
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