wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients
A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 colorectal-cancer
Started May 2012
Typical duration for phase_2 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 21, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedNovember 29, 2012
November 1, 2012
2.6 years
November 21, 2012
November 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival which is calculated from the start of treatment to disease progression or death
eight weeks
Secondary Outcomes (1)
Objective response rate which includes complete response(CR) and partial response(PR) participants
eight weeks
Other Outcomes (1)
Overall survival which is calculated from the start to treatment to the death
eight months
Study Arms (2)
FOLFIRI
ACTIVE COMPARATORFOLFIRI regimen
wXELIRI regimen
EXPERIMENTALwXELIRI
Interventions
irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin Lin, PhD, MD
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
November 21, 2012
First Posted
November 29, 2012
Study Start
May 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
November 29, 2012
Record last verified: 2012-11