Colorectal Cancer
Conditions
Keywords
advanced colorectal cancer, FOLFIRI, XELIRI
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.
Interventions
DRUGwXELIRI regimen
irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
DRUGFOLFIRI regimen
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival which is calculated from the start of treatment to disease progression or death | eight weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame |
|---|---|
| Overall survival which is calculated from the start to treatment to the death | eight months |
Countries
China
Contacts
Primary ContactJin Li, PhD,MD
Outcome results
None listed