Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Recruitment status was Recruiting
The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer|
- progression free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]
- overall survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Drug: tac + folfox4
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4
Active Comparator: 2
Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
folfox4 will be done within 28 days after liver resection
We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874406
|Contact: jianmin xu, MD, PHDfirstname.lastname@example.org|
|Zhongshan Hospital, Fudan University||Recruiting|
|Shanghai, Shanghai, China, 200032|
|Contact: jianmin xu, MD, PHD 008613501984869 email@example.com|
|Principal Investigator: jianmin xu, MD, PHD|
|Principal Investigator:||jianmin xu, MD, PHD||department of general surgery, zhongshan hospital, fudan university|