Back to resultsPostoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer
Primary Purpose
Unresectable Liver Metastasis of Colorectal Cancer
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tac + folfox4
Folfox4
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Liver Metastasis of Colorectal Cancer focused on measuring liver metastasis, colorectal cancer
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
- with measurable unresectableliver metastasis
- without other metastasis
Exclusion Criteria:
- age >= 75
- severe major organ dysfunction
- WHO performance status of >1
- prior cancer therapy
- with other metastasis
Sites / Locations
- Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle.
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
progression free survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00869271
Brief Title
Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer
Official Title
Postoperative folfox4 Only vs folfox4 Plus TAC in the Treatment Unresectable Liver Metastasis of Colorectal Cancer: a Randomized,Prospective,Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate whether TAC plus FOLFOX4 are able to improve resection rate and overall survival in patients receiving primary colorectal tumor resection than given FOLFOX4 only.
Detailed Description
We administered three cycles FOLFOX4 plus on TAC (oxaliplatin, FUDR and MMC) or FOLFOX4 only to primary colorectal tumor resected patients with unresected liver metastasis. The study endpoints were resection rate of liver metastasis, progression-free survival, 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
Unresectable Liver Metastasis of Colorectal Cancer
Keywords
liver metastasis, colorectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
Arm Title
2
Arm Type
Active Comparator
Arm Description
folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle.
Intervention Type
Procedure
Intervention Name(s)
tac + folfox4
Intervention Description
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg
folfox4
Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle. After 3 cycles, patients will received transhepatic arterial chemotherapy(TAC) using oxaliplatin, fudr and mmc. Then begin folfox4 again.
Intervention Type
Procedure
Intervention Name(s)
Folfox4
Intervention Description
folfox4
Folfox4 chemotherapy was done within 28 days after primary surgery. Per 3 weeks, patients will receive one cycle
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years after diagnosis
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
5 years after diagonsis
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 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
with measurable unresectableliver metastasis
without other metastasis
Exclusion Criteria:
age >= 75
severe major organ dysfunction
WHO performance status of >1
prior cancer therapy
with other metastasis
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
Study Director
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Postoperative Folfox4 Only Versus Folfox4 Plus Transhepatic Arterial Chemotherapy (TAC) in the Treatment Unresectable Liver Metastasis of Colorectal Cancer
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