Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Phase 4
- Conditions
- Colorectal Cancer
- Interventions
- Drug: tac + folfox4Drug: folfox4
- Registration Number
- NCT00874406
- Lead Sponsor
- Fudan University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- age <= 75 years
- resectable liver metastasis
- remnant liver volume >= 70%
- without other organ metastasis or peritoneum metastasis
- without contradiction of cardiac and pulmonary diseases
Exclusion Criteria
- age > 75 years
- unresectable liver metastasis
- remnant liver volume < 50%
- with other organ metastasis or peritoneum metastasis
- with contradiction of cardiac and pulmonary diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 tac + folfox4 transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery. 2 folfox4 Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
- Primary Outcome Measures
Name Time Method progression free survival 5 years after operation
- Secondary Outcome Measures
Name Time Method overall survival 5 years after operation
Trial Locations
- Locations (1)
Zhongshan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China