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Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
Conditions
Colorectal Neoplasms
Conditions: official terms
Colorectal Neoplasms
Conditions: Keywords
Colorectal Neoplasms, Regional, Liver, Neoplasm Metastasis
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
Type: Procedure
Name: surgery
Type: Procedure
Overall Status
Recruiting
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 curative colorectal cancer resection.
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 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 74 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
- 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
Location
Zhongshan Hospital, Fudan University
Shanghai, China
Status: Recruiting
Start Date
December 2008
Completion Date
December 2014
Sponsors
Fudan University
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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