search
Back to results

Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

Primary Purpose

Liver Metastasis, Colorectal Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
TACE + folfox 4
TAC + folfox4
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Metastasis focused on measuring liver metastasis, colorectal cancer, oxaliplatine, transartery chemotherapy, embolision, Unresectable Liver Metastasis of Colorectal Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 UniversityRecruiting

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 chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. Then begin folfox4 again.

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.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

resection rate of liver metastasis progression-free survival

Full Information

First Posted
March 24, 2009
Last Updated
March 24, 2009
Sponsor
Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT00868569
Brief Title
Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer
Official Title
TAC vs TACE Plus folfox4 as the Treatment of Unresectalbe Liver Metastasis of Colorectal Cancer With Resection of the Primary Tumor: a Prospective, Randomized, Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (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 TAC plus FOLFOX4 or TACE 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 TAC(oxaliplatin,FUDR and MMC) or FOLFOX4 plus TACE(oxaliplatin,FUDR,MMC and embolision) 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
Liver Metastasis, Colorectal Cancer
Keywords
liver metastasis, colorectal cancer, oxaliplatine, transartery chemotherapy, embolision, Unresectable Liver Metastasis of 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 (Anticipated)

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 chemoembolision (TACE) using oxaliplatin, fudr, mmc and iodine. 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. 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)
TACE + folfox 4
Intervention Description
tace: oxaliplatin 100mg + fudr 1g + mmc 10mg + iodine 2ml folfox4
Intervention Type
Procedure
Intervention Name(s)
TAC + folfox4
Intervention Description
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg folfox4
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years after operation
Secondary Outcome Measure Information:
Title
resection rate of liver metastasis progression-free 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jianmin xu, MD, PHD
Phone
008613501984869
Email
xujmin@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
yunshi zhong, MD
Phone
008613564623481
Email
zhongamy2002@126.com
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
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

Transhepatic Arterial Chemotherapy (TAC) Versus Transcatheter Arterial Chemoembolization (TACE) Plus Folfox4 as the Treatment of Unresectable Liver Metastasis of Colorectal Cancer

We'll reach out to this number within 24 hrs