Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 colorectal-cancer
Started Jan 2008
Shorter than P25 for phase_4 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedApril 2, 2009
April 1, 2009
1.9 years
April 1, 2009
April 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
progression free survival
5 years after operation
Secondary Outcomes (1)
overall survival
5 years after operation
Study Arms (2)
1
EXPERIMENTALtranshepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
2
ACTIVE COMPARATORLiver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.
Interventions
tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4
Eligibility Criteria
You may qualify if:
- age \<= 75 years
- resectable liver metastasis
- remnant liver volume \>= 70%
- without other organ metastasis or peritoneum metastasis
- without contradiction of cardiac and pulmonary diseases
You may not qualify if:
- age \> 75 years
- unresectable liver metastasis
- remnant liver volume \< 50%
- with other organ metastasis or peritoneum metastasis
- with contradiction of cardiac and pulmonary diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jianmin xu, MD, PHD
department of general surgery, zhongshan hospital, fudan university
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 2, 2009
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
April 2, 2009
Record last verified: 2009-04