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

Phase 2

• Conditions: Colorectal Cancer
• Interventions: Drug: FOLFIRI regimen; Drug: wXELIRI regimen

• Registration Number: NCT01736904
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Status Verified: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-26
• Last Update Submitted: 2012-11-26
• Study First Posted: 2012-11-29
• Last Update Posted: 2012-11-29
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFIRI	FOLFIRI regimen	FOLFIRI regimen
wXELIRI regimen	wXELIRI regimen	wXELIRI

Primary Outcome Measures

Name	Time	Method
Progression free survival which is calculated from the start of treatment to disease progression or death	eight weeks

Secondary Outcome Measures

Name	Time	Method
Objective response rate which includes complete response(CR) and partial response(PR) participants	eight weeks	Objective response rate (ORR)= CR(complete response)+PR(partial response)

Trial Locations

Locations (1)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China