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A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

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.


Inclusion Criteria:



- Second-line treatment for advanced colorectal cancer,irinotecan was not previously
used.

- Age range 18-70 years old

- ECOG performance status 0-1

- Life expectancy of more than 3 months

- Adequate organ function

Exclusion Criteria:

- Previous serious cardiac disease

- History of other malignancies except cured basal cell carcinoma of skin and
carcinoma in-situ of uterine cervix

- Pregnant or lactating women

- chronic inflammatory bowel disease or intestinal obstruction

- Serious uncontrolled diseases and intercurrent infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival which is calculated from the start of treatment to disease progression or death

Outcome Time Frame:

eight weeks

Safety Issue:

Yes

Principal Investigator

Jin Lin, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

wXELIRI vs FOLFIRI in CRC

NCT ID:

NCT01736904

Start Date:

May 2012

Completion Date:

December 2015

Related Keywords:

  • Colorectal Cancer
  • advanced colorectal cancer
  • FOLFIRI
  • XELIRI
  • Colorectal Neoplasms

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