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PRODIGE 18: Cetuximab vs Bevacizumab in KRAS WT mCRC
NCT01442649Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2010
- Primary completion
- Oct 2015
- Countries
- 1
- Sponsor
- Unicancer
- Modality
- Monoclonal Antibodies
- Drugs
- KL-140bevacizumab
- Conditions
- colorectal cancer (metastatic) (mCRC)
01
Overview
Phase 2, randomised, open-label trial of KL-140 and bevacizumab in colorectal cancer (metastatic) (mCRC), sponsored by Unicancer. Started Dec 2010; status: completed.
02
Design
- Study design
- RandomizedOpen-label
03
Registry description
The main objective is to evaluate progression-free survival (PFS) at 4 months.
The secondary objectives are to evaluate the objective response rate (OR) (= complete responses (CR) and partial responses (PR)) according to the RECIST v1.1 criteria, the progression-free survival (PFS), the overall survival (OS), the overall survival from the date of the first-line chemotherapy used on the metastatic disease, the treatment tolerance (NCI CTC AE V4 criteria, except for peripheral neurological toxicity (Lévi Scale)), the quality of life according to the EORTC QLQ-C30 criteria.
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