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Trial Title:
Trial of Preoperative Hepatic and Regional Arterial Chemotherapy (PHRAC) to Prevent Postoperative Liver Metastasis of Colorectal Cancer
NCT ID:
NCT00643877
Condition:
Colorectal Neoplasms
Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Oxaliplatin
Conditions: Keywords:
Colorectal Neoplasms
Regional
Liver
Neoplasm Metastasis
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Preoperative hepatic and regional arterial chemotherapy using oxaliplatin, MMC and FUDR
Description:
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
Arm group label:
B
Intervention type:
Procedure
Intervention name:
surgery
Description:
radical surgery only
Arm group label:
A
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Investigator:
Last name:
jianmin xu, MD
Email:
Principal Investigator
Start date:
December 2008
Completion date:
December 2014
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Jiangyin People's Hospital
Agency class:
Other
Collaborator:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00643877
