Gunma study - Oxaliplatin-based chemotherapy and Avastin following Irinotecan-based chemotherapy with Erbitux in metastatic colorectal cancer
- Conditions
- Metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000007117
- Lead Sponsor
- Gunma University Graduate school of Medicine Department of General surgical science clinical study group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 53
Not provided
1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease-free interval 2) Symptomatic brain metastases 3) Severe myelosuppression 4) Watery diarrhea 5) Severe infectious disease 6) Interstitial lung disease or pulmonary fibrosis 7) Comorbidity or history of severe heart failure 8) Sensory alteration or paresthesia interfering with function 9) Need to drain malignant coelomic fluid 10) Severe comorbidity 11) Paralytic or mechanical bowel obstruction 12) Jaundice 13) Patient taking Atazanavir sulphate 14) Men/women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test 15) History of severe allergy 16) History of allergy for Cetuximab, Bevacizumab, fluoropyrimidine, irinotecan, oxaliplatin and other platinating agent 17) Prior treatment of Cetuximab, Bevacizumab, fluoropyrimidine, irinotecan and oxaliplatin Any other cases who are regarded as inadequate for study enrollment by investigators
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total Progression free survival (PFS1+PFS2): PFS during first-line (PFS1) and PFS during second-line (PFS2)
- Secondary Outcome Measures
Name Time Method Progression free survival during first-line (PFS1) Progression free survival during second-line (PFS2) Response rate during first-line (RR1) Response rate during second-line (RR2) Tumor shrinkage rate at 8 weeks in first-line Overall survival (OS) Survival beyond progression (SBP) Safety