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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01736904
Recruitment Status : Unknown
Verified November 2012 by Jin Li, Fudan University.
Recruitment status was:  Recruiting
First Posted : November 29, 2012
Last Update Posted : November 29, 2012
Information provided by (Responsible Party):
Jin Li, Fudan University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: wXELIRI regimen Drug: FOLFIRI regimen Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients
Study Start Date : May 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: FOLFIRI
FOLFIRI regimen
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
Experimental: wXELIRI regimen
Drug: wXELIRI regimen
irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
Other Name: wXELIRI

Primary Outcome Measures :
  1. Progression free survival which is calculated from the start of treatment to disease progression or death [ Time Frame: eight weeks ]

Secondary Outcome Measures :
  1. Objective response rate which includes complete response(CR) and partial response(PR) participants [ Time Frame: eight weeks ]
    Objective response rate (ORR)= CR(complete response)+PR(partial response)

Other Outcome Measures:
  1. Overall survival which is calculated from the start to treatment to the death [ Time Frame: eight months ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01736904

Contact: Jin Li, PhD,MD 64175590-5109

China, Shanghai
Fudan University Cancer Hospital Recruiting
Shanghai, Shanghai, China, 200032
Principal Investigator: Jin Li, PhD,MD         
Sponsors and Collaborators
Fudan University
Principal Investigator: Jin Lin, PhD, MD Fudan University

Responsible Party: Jin Li, Dr, Fudan University Identifier: NCT01736904     History of Changes
Other Study ID Numbers: wXELIRI vs FOLFIRI in CRC
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: November 29, 2012
Last Verified: November 2012

Keywords provided by Jin Li, Fudan University:
advanced colorectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases