Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer (PHRAC)
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|ClinicalTrials.gov Identifier: NCT00643877|
Recruitment Status : Unknown
Verified March 2009 by Fudan University.
Recruitment status was: Recruiting
First Posted : March 26, 2008
Last Update Posted : March 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR Procedure: surgery||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective,Multi-Center,Randomized Control Trial of Preoperative Hepatic and Regional Arterial Chemotherapy(PHRAC) Using Oxaliplatin, Fluorodeoxyuridine(FUDR) and Mitomycin C(MMC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2014|
PHRAC was performed 7 days before surgery. Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
Procedure: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
PHRAC which included of two parts(common hepatic artery chemotherapy and main tumor supplying artery chemotherapy) was performed 7 days before surgery： common hepatic artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg main tumor supplying artery chemotherapy: FUDR 500mg, Oxaliplatin 50mg and MMC 10mg
No Intervention: A
Adjuvant chemotherapy using FOLFOX7 was done for 8 cycle with 28 days after surgery.
radical surgery only
- 5 years disease-free survival [ Time Frame: 5 years after operation ]
- 5 years overall survival and liver metastasis-free survival [ Time Frame: 5 years after operation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643877
|Contact: jianmin xu, MDemail@example.com|
|Zhongshan Hospital, Fudan University||Recruiting|
|Shanghai, China, 200032|
|Principal Investigator: jianmin xu, MD|
|Study Chair:||jianmin xu, MD||department of general surgery, zhongshan hospital, fudan university|