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Trial Title:
Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
NCT ID:
NCT00868569
Condition:
Liver Metastasis
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Leucovorin
Fluorouracil
Oxaliplatin
Conditions: Keywords:
liver metastasis
colorectal cancer
oxaliplatine
transartery chemotherapy
embolision
Unresectable Liver Metastasis of Colorectal Cancer
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
TACE + folfox 4
Description:
tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml
folfox4
Arm group label:
1
Intervention type:
Procedure
Intervention name:
TAC + folfox4
Description:
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
folfox4
Arm group label:
2
Summary:
The purpose of this study is to investigate whether TAC plus FOLFOX4 or TACE plus folfox4
are able to improve resection rate and overall survival in patients receiving primary
colorectal tumor resection than given FOLFOX4 only.
Detailed description:
We administered three cycles FOLFOX4 plus TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus
TACE(oxaliplatin,FUDR,MMC and embolision) to primary colorectal tumor resected patients
with unresected liver metastasis. The study endpoints were resection rate of liver
metastasis, progression-free survival, overall survival as evaluated by intent-to-treat
analysis.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- age < 75 years with histologically proven adenocarcinoma of the colon or rectum
- 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:
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- with other metastasis
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
jianmin xu, MD, PHD
Phone:
008613501984869
Email:
xujmin@yahoo.com.cn
Investigator:
Last name:
jianmin xu, MD, PHD
Email:
Principal Investigator
Start date:
January 2008
Completion date:
December 2010
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00868569
