JPRN-UMIN000023026
Completed
Phase 2
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 - 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
Department of Clinical Oncology, St. Marianna University School of Medicine0 sites54 target enrollmentAugust 1, 2016
ConditionsColorectal cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colorectal cancer
- Sponsor
- Department of Clinical Oncology, St. Marianna University School of Medicine
- Enrollment
- 54
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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