Status:
UNKNOWN
Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Ruijin Hospital
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate whether preoperative hepatic and regional arterial chemotherapy are able to prevent liver metastasis and improve overall survival in patients receiving cura...
Detailed Description
We administered FUDR, MMC and Oxaliplatin as preoperative hepatic and regional arterial chemotherapy (PHRAC) to patients with Stage II or Stage III colorectal cancer without apparent liver metastasis ...
Eligibility Criteria
Inclusion
- 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
- Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan
Exclusion
- age \>= 75
- severe major organ dysfunction
- WHO performance status of \>1
- prior cancer therapy
- Stage I or Stage IV
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00643877
Start Date
December 1 2008
End Date
December 1 2014
Last Update
March 25 2009
Active Locations (1)
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1
Zhongshan Hospital, Fudan University
Shanghai, China, 200032