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Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
Conditions
Liver Metastasis - Colorectal Cancer
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis
Conditions: Keywords
liver metastasis, colorectal cancer, oxaliplatine, transartery chemotherapy, embolision, Unresectable Liver Metastasis of Colorectal Cancer
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: TACE + folfox 4
Type: Procedure
Name: TAC + folfox4
Type: Procedure
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: jianmin xu, MD, PHD - 008613501984869 - xujmin@yahoo.com.cn
Start Date
January 2008
Completion Date
December 2010
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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