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OS vs XELOX in Advanced or Recurrent Colorectal Cancer
NCT00677144Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2008
- Primary completion
- Apr 2012
- Countries
- 1
- Sponsor
- Hallym University Medical Center
- Modality
- Small Molecules
- Drugs
- tegafur
- Conditions
- colorectal cancer (CRC)
01
Overview
Phase 2, randomised, open-label trial of tegafur in colorectal cancer (CRC) (2 arms), sponsored by Hallym University Medical Center. Primary endpoint: Overall Response Rate at 4 years. Started Apr 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
OS (oxaliplatin+S-1)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO divided by two on D1-14 every 21 days
XELOX (oxaliplatin+capecitabine)
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO divided by two on D1-14 every 21 days
03
Who it enrols
Patients aged 18-75 with unresectable, locally advanced or metastatic colorectal adenocarcinoma, measurable by RECIST, ECOG PS <=2, adequate organ function, and no prior chemotherapy for advanced disease (prior adjuvant without oxaliplatin allowed).
04
Endpoints
Primary
Overall Response Rate
Secondary
Safety
Time to Progression
Overall Survival
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