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A phase II trial of lenvatinib in patients with metastatic colorectal cancer after standard chemotherapy (NCCH1503,Lemon trial)

Phase 2
Conditions
colorectal cancer
Registration Number
JPRN-UMIN000023446
Lead Sponsor
ational Cancer Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

1)Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible 2)Infections requiring systemic therapy 3)Fever of >=38 degrees Celsius at the time of registration 4)Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia and grade 2 peripheral neurotoxicity 5)Pregnant or breast-feeding women,or women suspected of being pregnant 6)Mental disease interfering taking part in the trial 7)Taking continuous systemic steroids and/or other immunosuppressive drugs(orally or intravenously) 8)HIV antibody positive 9)Interstitial pneumonia and/or pulmonary fibrosis and/or severe pulmonary emphysema diagnosed by chest CT imaging 10)History of any of the followings; unstable angina and transient ischemic attacks within 6 months before registration, or heart attack,pulmonary embolism,deep vein thrombosis,brain bleeding,cerebral infarction and arterial thromboembolism

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease control rate
Secondary Outcome Measures
NameTimeMethod
Adverse events Overall response rate Progression-free survival Overall survival
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