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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
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
 Drug: wXELIRI regimen
Drug: FOLFIRI regimen
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)


Other Outcome Measures:
  • Overall survival which is calculated from the start to treatment to the death [ Time Frame: eight months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
wXELIRI
 Drug: wXELIRI regimen
irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
Other Name: wXELIRI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736904

Contacts
Contact: Jin Li, PhD,MD 64175590-5109 fudanlijin@163.com

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

No publications provided

Responsible Party: Jin Li, Dr, Fudan University
ClinicalTrials.gov Identifier: NCT01736904     History of Changes
Other Study ID Numbers: wXELIRI vs FOLFIRI in CRC
Study First Received: November 21, 2012
Last Updated: November 26, 2012
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
advanced colorectal cancer
FOLFIRI
XELIRI

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

ClinicalTrials.gov processed this record on June 18, 2013