JPRN-UMIN000005216
Completed
Phase 2
Randomized phase II trial of FOLFIRI with either panitumumab or bevacizumab as second-line treatment in patients with KRAS wild metastatic colorectal cancer refractory to oxaliplatin and bevacizumab with exploratory analysis to predict treatment efficacy and prognosis - FOLFIRI+Pmab vs FOLFIRI+BV as second-line for colorectal cancer
ConditionsColorectal cancer
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Colorectal cancer
- Sponsor
- West Japan Oncology Group
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) previous history of chemotherapy including irinotecan, cetuximab, or panitumumab 2\) symptomatic brain metastasis or brain metastasis with under medication 3\) intestinal obstruction 4\) uncontrollable ascites or pleural effusion 5\) uncontrollable diarrhea 6\) having other active malignancies 7\) having active infections 8\) pulmonary fibrosis or interstitial pneumonia 9\) serious comorbidities, such as uncontrollable diabetes mellitus, severe heart disease (NYHA\>III), renal failure, and liver failure 10\) History of arterial thromboembolic events such as unstable angia, myocardial infarction, brain hemorrhage, and brain infarction within 6 months. 11\) having wound healing problem (excluding central venous port) 12\) History of major surgery within 28 days or 14 days after colostomy. 13\) Meningitis carcinomatosis or uncontrollable seizures, serious mental problem or neurologic disorders 14\) continuous steroid administration 15\) serious drug allergy 16\) HIV infection 17\) Pregnant or lactating female 18\) Other serious medical conditions.
Outcomes
Primary Outcomes
Not specified
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