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FOLFOXIRI vs FOLFOX in Metastatic Colorectal Cancer
NCT02128425Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2014
- Primary completion
- Feb 2017
- Countries
- 1
- Sponsor
- Sun Yat-sen University
- Modality
- Nanoparticles, Monoclonal Antibodies, Small Molecules
- Conditions
- metastatic colorectal cancer (mCRC)
01
Overview
Phase 2, randomised, open-label trial of irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab in metastatic colorectal cancer (mCRC) (2 arms), sponsored by Sun Yat-sen University. Primary endpoint: Progression-free survival after induction and maintenance chemotherapy at 18 months. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
FOLFOXIRI
Irinotecan + Oxaliplatin + Leucovorin + 5-FU
FOLFOX
Oxaliplatin + Leucovorin + 5-FU
03
Who it enrols
Patients with histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease, ECOG PS 0-2, and no prior chemotherapy for metastatic disease.
04
Endpoints
Primary
Progression-free survival after induction and maintenance chemotherapy
Secondary
Progression-free survival after re-introduction of chemotherapy
Response rate during re-introduction of chemotherapy
Early tumor shrinkage rate
Overall survival
Toxicity and safety
Quality of life (QLQ C30)
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