Phase II study of FOLFIRI + cetuximab as induction chemotherapy followed by FOLFIRI + bevacizumab based on early tumor shrinkage in chemotherapy-naive patients with RAS wild-type colorectal cancer
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000023026
- Lead Sponsor
- Department of Clinical Oncology, St. Marianna University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 54
Not provided
1) Previous treatment with irinotecan, bevacizumab, cetuximab/panitumumab 2) Symptomatic brain metastasis 3) Intestinal paralysis/obstruction 4) Massive pleural effusion, ascites, or pericardial effusion 5) Uncontrolled diarrhea 6) Active synchronous or metachronous malignancy 7) Severe infectious disease 8) Grade2 or higher skin toxicity 9) Interstitial pneumonia or pulmonary fibrosis 10) Serious complication(uncontrolled diabetes, severe cardiac disease, renal failure, liver failure) 11) History of thromboembolism 12) Unhealed wounds 13) Previous treatment with radiotherapy for primary disease 14) Administration of aspirin 15) Carcinomatous meningitis, uncontrolled epilepsy, mental disorder 16) Systemic administration of steroid 17) History of severe allergy 18) Positive for HBs antigen 19) Women who are pregnant or patients who are unwilling to avoid pregnancy 20) Patients who are inappropriate for the study in the opinion of the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method early tumor shrinkage(ETS) rate PFS of ETS positive and negative depth of response(DpR) Time to DpR time to treatment failure(TTF) response rate overall survival safety