stage III colon cancer patients who received an adjuvant chemotherapy,
Conditions
Interventions
an omitted of bolus dose of fluorouracil of modified FOLFOX6 regimen,reduction of oxaliplatin dose of modified FOLFOX6 regimen,
from 85 to 65 milligram per square meter
Experimental Drug,Active Comparator Drug
an omitted of bolus dose of 5-
FU group,an oxaliplatin reduction group
Sponsors
-
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. An age is greater than or equal to 18 2. histologically confirmed AJCC/UICC stage III or IV adenocarcinoma colon cancer 3. histologically confirmed AJCC/UICC stage IV adenocarcinoma rectal cancer 4. history of neutropenia (absolute neutrophils count < 1,500) from previous chemotherapy (FOLFOX4 or FOLFOL6 regimen) 5. adequate organ function 6. ECOG performance status 0 to 1 7. signed written informed consent obtained prior to any study specific procedures
Exclusion criteria
Exclusion criteria: 1. eGFR less than 15 2. abnormal liver function test 3. other malignancies within the last 5 years 4. history of clinically relevant psychritic disability 5. previous radiotherapy within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of recurrent neutropenia within 2 cycles of chemotherapy (mFOLFOX6 regimen) rate | — |
Secondary
| Measure | Time frame |
|---|---|
| delay time for next chemotherapy cycle, absolute neutrophil, rate of grade 3-5 adverse event count, within 2 cycles of chemotherapy (mFOLFOX6 regimen) mean | — |
Countries
Thailand
Contacts
Public Contactwinat kaewtan
Unaffiliated
Outcome results
None listed