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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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase IV Treatment Active 18 to 74 Other 2009-03
NCT00868569

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Medical Center of Fudan University

jianmin xu, MD, PHD

Study Director

jianmin xu, MD, PHD		Ph: 008613501984869
		Email: xujmin@yahoo.com.cn

yunshi zhong, MD		Ph: 008613564623481
		Email: zhongamy2002@126.com

Trial Sites

China

shanghai

Medical Center of Fudan University

jianmin xu, MD, PHD Ph: 008613501984869

Email: xujmin@yahoo.com.cn

jianmin xu, MD, PHD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00868569
Information obtained from ClinicalTrials.gov on March 25, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.