Back to resultswXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
wXELIRI regimen
FOLFIRI regimen
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring advanced colorectal cancer, FOLFIRI, XELIRI
Eligibility 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
Sites / Locations
- Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FOLFIRI
wXELIRI regimen
Arm Description
FOLFIRI regimen
wXELIRI
Outcomes
Primary Outcome Measures
Progression free survival which is calculated from the start of treatment to disease progression or death
Secondary Outcome Measures
Objective response rate which includes complete response(CR) and partial response(PR) participants
Objective response rate (ORR)= CR(complete response)+PR(partial response)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01736904
Brief Title
wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
Official Title
A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
advanced colorectal cancer, FOLFIRI, XELIRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FOLFIRI
Arm Type
Active Comparator
Arm Description
FOLFIRI regimen
Arm Title
wXELIRI regimen
Arm Type
Experimental
Arm Description
wXELIRI
Intervention Type
Drug
Intervention Name(s)
wXELIRI regimen
Other Intervention Name(s)
wXELIRI
Intervention Description
irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
Intervention Type
Drug
Intervention Name(s)
FOLFIRI regimen
Other Intervention Name(s)
FOLFIRI
Intervention Description
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
Primary Outcome Measure Information:
Title
Progression free survival which is calculated from the start of treatment to disease progression or death
Time Frame
eight weeks
Secondary Outcome Measure Information:
Title
Objective response rate which includes complete response(CR) and partial response(PR) participants
Description
Objective response rate (ORR)= CR(complete response)+PR(partial response)
Time Frame
eight weeks
Other Pre-specified Outcome Measures:
Title
Overall survival which is calculated from the start to treatment to the death
Time Frame
eight months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Li, PhD,MD
Phone
64175590-5109
Email
fudanlijin@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Lin, PhD, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Cancer Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Li, PhD,MD
12. IPD Sharing Statement
Learn more about this trial
wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
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