wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients

This study is currently recruiting participants.
Verified November 2012 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Jin Li, Fudan University
ClinicalTrials.gov Identifier:
NCT01736904
First received: November 21, 2012
Last updated: November 26, 2012
Last verified: November 2012

November 21, 2012
November 26, 2012
May 2012
December 2014   (final data collection date for primary outcome measure)
Progression free survival which is calculated from the start of treatment to disease progression or death [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01736904 on ClinicalTrials.gov Archive Site
Objective response rate which includes complete response(CR) and partial response(PR) participants [ Time Frame: eight weeks ] [ Designated as safety issue: Yes ]
Objective response rate (ORR)= CR(complete response)+PR(partial response)
Same as current
Overall survival which is calculated from the start to treatment to the death [ Time Frame: eight months ] [ Designated as safety issue: Yes ]
Same as current
 
wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients

The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of wXELIRI is not less than FOLFIRI with tolerable toxicity.

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
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: wXELIRI regimen
    irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
    Other Name: wXELIRI
  • Drug: FOLFIRI regimen
    irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
    Other Name: FOLFIRI
  • Active Comparator: FOLFIRI
    FOLFIRI regimen
    Intervention: Drug: FOLFIRI regimen
  • Experimental: wXELIRI regimen
    wXELIRI
    Intervention: Drug: wXELIRI regimen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Jin Li, PhD,MD 64175590-5109 fudanlijin@163.com
China
 
NCT01736904
wXELIRI vs FOLFIRI in CRC
No
Jin Li, Fudan University
Fudan University
Not Provided
Principal Investigator: Jin Lin, PhD, MD Fudan University
Fudan University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP