A Phase II Study of Neoadjuvant FOLFOX6 Plus Cetuximab in Patients With Colorectal Cancer and Unresectable Liver Metastasis
Sponsor study identifier
interventional
73
1 country
1
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2012
Actual (reported)Study Completion
June 2012
Actual (reported)An innovative therapeutic strategy to increase the complete resection rate is of utmost importance in order to enhance survival in colorectal cancer patients with unresectable liver-only metastasis. Therefore, the investigators propose a prospective study of neoadjuvant chemotherapy using FOLFOX6 plus cetuximab to convert initially unresectable liver metastasis to potentially resectable disease.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 27, 2008
Actual (reported)August 29, 2008
Actual (reported)January 2012
Actual (reported)June 2012
Actual (reported)To evaluate overall R0 resection rates following neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver-only metastasis
18 months
Response rate (according to RECIST)
24 months
Progression-free survival time
24 months
Overall survival timeToxicity profile (according to NCI CTCAE v3)
24 months
Correlative analyses between pretreatment EGFR, KRAS mutation and response rate/survival
24 months
NEO : Neoadjuvant therapy with FOLFOX6 plus cetuximab
Neoadjuvant FOLFOX6/cetuximab
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Samsung Medical Center
Seoul, 135-710, South Korea
Young Suk Park, M.D.,Ph.D.
Samsung Medical Center, Seoul, Korea
73 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2008
First Posted
August 29, 2008
Study Start
June 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
January 2012
Actual (reported)Study Completion
June 2012
Actual (reported)Last Updated
June 14, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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