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FOLFOX vs FOLFIRI Sequence in Advanced Gastric Cancer
NCT01138904Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2009
- Primary completion
- Sep 2013
- Countries
- 1
- Modality
- Nanoparticles, Monoclonal Antibodies, DNA Intercalators/Alkylators
- Conditions
- gastric cancer (GC)
01
Overview
Phase 2, randomised, open-label trial of oxaliplatin and irinotecan hydrochloride liposome injection (II) + temozolomide + bevacizumab in gastric cancer (GC) (2 arms). Primary endpoint: Response rate by RECIST at 6 months. Started Sep 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
IROX arm
FOLFIRI followed by FOLFOX
OXIR arm
FOLFOX followed by FOLFIRI
03
Who it enrols
Patients with histologically confirmed gastric cancer, ECOG PS < 3, measurable lesion, adequate organ function, and no prior chemotherapy for palliative setting.
04
Endpoints
Primary
Response rate by RECIST
Secondary
Progression Free Survival
Overall Survival
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