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
18 Years
74 Years
Both
Colorectal Neoplasms
Trial Information
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
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 based on a thorough preoperative evaluation. The study endpoints
were disease-free survival, overall survival, and liver metastasis-free survival as
evaluated by intent-to-treat analysis.
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
- 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 Criteria:
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- Stage I or Stage IV
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
5 years disease-free survival
Outcome Time Frame:
5 years after operation
Safety Issue:
Yes
Principal Investigator
jianmin xu, MD
Investigator Role:
Study Chair
Investigator Affiliation:
department of general surgery, zhongshan hospital, fudan university
Authority:
China: Food and Drug Administration
Study ID:
2008－46
NCT ID:
NCT00643877
Start Date:
December 2008
Completion Date:
December 2014
Related Keywords:
- Colorectal Neoplasms
- Colorectal Neoplasms
- Regional
- Liver
- Neoplasm Metastasis
- Neoplasms
- Colorectal Neoplasms
- Neoplasm Metastasis
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