Back to resultsPreoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tac + folfox4
folfox4
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring colorectal cancer, liver metastasis, neoadjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria:
- age <= 75 years
- resectable liver metastasis
- remnant liver volume >= 70%
- without other organ metastasis or peritoneum metastasis
- without contradiction of cardiac and pulmonary diseases
Exclusion Criteria:
- age > 75 years
- unresectable liver metastasis
- remnant liver volume < 50%
- with other organ metastasis or peritoneum metastasis
- with contradiction of cardiac and pulmonary diseases
Sites / Locations
- Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Outcomes
Primary Outcome Measures
progression free survival
Secondary Outcome Measures
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00874406
Brief Title
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Official Title
Preoperative Transhepatic Arterial Chemotherapy in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.
Detailed Description
We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, liver metastasis, neoadjuvant chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Intervention Type
Drug
Intervention Name(s)
tac + folfox4
Intervention Description
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4
Intervention Type
Drug
Intervention Name(s)
folfox4
Intervention Description
folfox4 will be done within 28 days after liver resection
Primary Outcome Measure Information:
Title
progression free survival
Time Frame
5 years after operation
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
5 years after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age <= 75 years
resectable liver metastasis
remnant liver volume >= 70%
without other organ metastasis or peritoneum metastasis
without contradiction of cardiac and pulmonary diseases
Exclusion Criteria:
age > 75 years
unresectable liver metastasis
remnant liver volume < 50%
with other organ metastasis or peritoneum metastasis
with contradiction of cardiac and pulmonary diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianmin xu, MD, PHD
Phone
008613501984869
Email
xujmin@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD, PHD
Organizational Affiliation
department of general surgery, zhongshan hospital, fudan university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD, PHD
Phone
008613501984869
Email
xujmin@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
jianmin xu, MD, PHD
12. IPD Sharing Statement
Learn more about this trial
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
We'll reach out to this number within 24 hrs