Skin Toxicity Prevention Protocol with Panitumumab treatment for Metastatic Colorectal Cancer
Phase 2
- Conditions
- Metastatic Colorectal Cancer
- Registration Number
- JPRN-UMIN000011485
- Lead Sponsor
- Multicenter Study Group of Osaka (MCSGO), Colorectal Cancer Treatment Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1)Previous history of chemotherapy with anti EGFR antibody 2)Contraindications to panitumumab 3)Complications or history of interstitial pneumonia, pulmonary fibrosis 4)Pregnant woman, possibly pregnant woman 5) Contraindications to clarithromycin 6)Any other cases who are not suitable for combination chemotherapy 7) 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
Name Time Method incidence rates of skin toxicity (>=Grade2) with or without antibiotics during the 6 weeks from the treatment started
- Secondary Outcome Measures
Name Time Method time to the first appearance of skin toxicity (Grade>=2), incidence rates of skin toxicity(Grade>=3), response rate, disease control rate and progression free survival(each line, each chemotherapy regimen), difference between patients' and doctors' view to the side effects