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Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer

Phase 1
Conditions
metastatic colorectal cancer
Registration Number
JPRN-UMIN000010639
Lead Sponsor
Japan Clinical Cancer Research Organization
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
16
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) Comorbidity or history of interstitial lung disease or pulmonary fibrosis. 5) Comorbidity or history of severe heart disease. 6) Sensory alteration or paresthesia interfering with function. 7) Large quantity of pleural, abdominal or cardiac effusion. 8) Severe comorbidity (renal failure, liver failure, hypertension, etc.) 9) Prior radiotherapy for primary or metastases tumors. 10) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test. 11) Any other cases who are regarded as inadequate for sydy enrollment by investigators.

Study & Design

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