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on-resectable colorectal liver metastases treated with cetuximab induction toward liver R0 resection trial

Phase 2
Conditions
on-resectable colorectal liver metastases
Registration Number
JPRN-UMIN000007923
Lead Sponsor
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Prior local therapy for liver metastases (2) Severe comorbidity (3) A past history of drug allergy (needs continuation therapy) (4) A past history of Interstitial lung disease (5) Patients who has not recovered from previous cancer treatment to less than Grade 1 toxicity (6) Fully recovered from surgical treatment within 4 weeks before registration (7) Received widespread radiation therapy within 6 weeks before registration (8) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval (9) Severe infectious disease (10) Pleural effusion, ascites fluid and the pericardial fluid needing treatment (11) Watery diarrhea (watery colostomy output without trouble during patient's daily living is allowed) (12) Chronic systemic treatment of corticosteroid (13) Bleeding tendency, coagulation disorder, abnormality of coagulation factor, or administered anticoagulant (14) HBsAg positive, HCV-Ab positive or HIV positive (15) Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test (16) Psychological disorder (17) Considered not appropriate for surgery (18) Patients who are judged inappropriate for the entry into the study by the investigator

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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