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Multicenter Phase II trial of Irinotecan plus S-1 with cetuximab (IRIS/Cet) in patients with EGFR positive and KRAS wild type of advanced/metastatic colorectal cancer

Phase 2
Conditions
advanced/metastatic colorectal cancer
Registration Number
JPRN-UMIN000004882
Lead Sponsor
PO Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
80
Inclusion Criteria

Not provided

Exclusion Criteria

1) History of severe allergy 2) Simultaneous or metachronous double cancers 3) Symptomatic brain metastasis 4) Severe infectious disease 5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 6) Paralytic or mechanical bowel obstruction 7) Massive pleural effusion or ascites 8) Wattery diarrhea 9) Patients who is receiving Atazanavir Sulfate or Flucytosine 10) Pregnant or lactating women or women of childbearing potential 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Response rate
Secondary Outcome Measures
NameTimeMethod
Disease control rate
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