Early tumor shrinkage of Cetuximab and mFOLFOX6 in RAS-wild type unresectable metastatic colorectal cancer.
Phase 2
- Conditions
- RAS-wild type colorectal cancer
- Registration Number
- JPRN-UMIN000015339
- Lead Sponsor
- Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1.Severe infection 2.Prior hypersensitivity reaction to drugs useing in this trial 3.Dementia, altered mental status, or any psychiatric condition 4.Severe body fruid (ascites,pleural effusion.pericardiac effsion) 5.Severe stenotic primary lesion 6.Recieved radiotherapy to target lesion 7.Medical conditions that compromise the patient's ability to give informed consent or to complete the protocol 8.Prior treatment with drugs targeting EGFR such as cetuximab, panitumumab and so on 9.Active other malignant disease 10.Symptomatic brain metastasis 11.Uncontroled severe diarrhea 12.Pregnancy or lactation 13.Women and partners of women of childbearing potential cannot agree to use adequate contraception
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ETS(Early Tumor Shrinkage) rate
- Secondary Outcome Measures
Name Time Method PFS:Progression free survival TTF:Time to treatment failure Adverse events ORR: overall response rate Pathological response rate OS:Overall survival Treatment completion rate RDI: relative dose intensity Resection rates of metastatic sites R0 rate