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A phase 2 study of combination therapy with irinotecan/ S-1 (IRIS) plus panitumumab as second-line chemotherapy for metastatic colorectal cancer

Not Applicable
Conditions
colonrectal cancer
Registration Number
JPRN-UMIN000004659
Lead Sponsor
The University of Tokushima Graduate School
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

1)Patients with the past history of severe allergic reactions 2)Patients with the past history of treatment of irinotecan and panitumumab 3) Patient with active double cancer 4)Patient with active infection 5) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 6)Patients with severe interstitial pneumonitis or pulmonary fibrosis 7)Patients with uncontrollable ascites and pleural effusion 8)Patients with diarrhea 9) Patient with regular use of furucytocin or fenytoin 10)Patients with symptomatic brain metastasis 11) pregnant or nursing patient or with intent to bear baby 12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Completion rate of protocol therapy
Secondary Outcome Measures
NameTimeMethod
Response rate Overall survival Progression free survival Adverse events
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