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Phase II study of panitumumab rechallenge in the third-line therapy in patients with KRAS wild-type metastatic colorectal cancer

Phase 2
Conditions
metastatic colorectal cancer
Registration Number
JPRN-UMIN000011440
Lead Sponsor
onprofit Organization Japan Clinical Cancer Research Organization
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
35
Inclusion Criteria

Not provided

Exclusion Criteria

(1) Synchronous multiple maligmancy 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 comobidity (renal failure, liver failure, hypertensio, etc) (9) Prio radiotherapy for primary and metastatic tumor (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 study enrillment by investigators

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
3-Month Progression Free Survival Rate
Secondary Outcome Measures
NameTimeMethod
response rate disease control rate overall survival progression free survival time to treatment failure safety
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