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mFOLFOX6 in Advanced Colorectal Cancer
NCT00209703Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2005
- Countries
- 1
- Sponsor
- Hokkaido Gastrointestinal Cancer Study Group
- Modality
- DNA Intercalators/Alkylators, Orthosteric Ligands, Metabolically Activated Prodrugs
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, open-label, single-arm trial of oxaliplatin, levoleucovorin and fluorouracil in colorectal cancer (CRC), sponsored by Hokkaido Gastrointestinal Cancer Study Group. Primary endpoint: Incidence and severity of adverse event. Started Jan 2005; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
mFOLFOX6
Single arm receiving mFOLFOX6 regimen
03
Who it enrols
Patients aged 15-75 with histological stage IV colorectal adenocarcinoma, ECOG 0-2, adequate organ function, and no more than 2 prior chemotherapy regimens.
04
Endpoints
Primary
Incidence and severity of adverse event
Secondary
Clinical response rate
Disease-free survival
Overall survival
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