A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients
The combination of irinotecan and fluorouracil drugs regimen is frequently used in patients
with advanced colorectal cancer. According to the previous data, higher rate of diarrhea was
observed in the combination of irinotecan and capecitabine (XELIRI) regimen, compared to the
combination of irinotecan and 5-fluorouracil (FOLFIRI) regimen. However, the modified weekly
XELIRI regimen, which was investigated in our previous single armed study, show tolerate
toxicities compared with FOLFIRI, without compromising efficacy. It is supposed that wXELIRI
regimen is no less less than FOLFIRI regimen in efficacy.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival which is calculated from the start of treatment to disease progression or death
eight weeks
Yes
Jin Lin, PhD, MD
Principal Investigator
Fudan University
China: Ethics Committee
wXELIRI vs FOLFIRI in CRC
NCT01736904
May 2012
December 2015
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