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Feasibility study of neoadjuvant mFOLFOX6 plus cetuximab in patients with resectable liver limited metastases from colorectal cancer harboring KRAS wild type

Phase 2
Conditions
Metastatic colorectal cancer
Registration Number
JPRN-UMIN000007545
Lead Sponsor
ational Cancer Center Hospital East
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

Exclusion Criteria

(1)Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (2)Symptomatic brain metastases (3)Severe infectious disease (4)Interstitial lung disease or pulmonary fibrosis (5)Comorbidity or history of heart failure (6)Sensory alteration or paresthesia interfering with function (7)Severe comorbidity (renal failure, liver failure, hypertension, etc) (8)History of severe allergy (9)Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Treatment completion rate
Secondary Outcome Measures
NameTimeMethod
Safety(CTCAE ver4.0), RR, Liver resectability, R0 rate, Postoperative complications, Explore the appropriate treatment duration from ICG (after 4 and 6 course) and CT
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