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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: wXELIRI regimen
* Drug: FOLFIRI regimen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FOLFIRI<br>FOLFIRI regimen | Drug: FOLFIRI regimen<br>* irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks<br>* Other names: FOLFIRI;|
| Experimental: wXELIRI regimen<br>wXELIRI | Drug: wXELIRI regimen<br>* irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days<br>* Other names: wXELIRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival which is calculated from the start of treatment to disease progression or death |  | eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate which includes complete response(CR) and partial response(PR) participants | Objective response rate (ORR)= CR(complete response)+PR(partial response) | eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced colorectal cancer, FOLFIRI, XELIRI