Patients with advanced and/or recurrent colorectal cancer
Conditions
Interventions
Group A:mFOLFOX6 Day 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ------------- | 5-FU 400mg/m2 iv R
Sponsors
OGSG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) colon cancer proven histologically 2) with measurable metastatic lesions 3) without prior chemotherapy or with chemotherapy which is completed Before 6 months of registration 4) without radiation therapy 5) age: =>20 and 75=> 6) Performance Status: 0-1 (ECOG criteria) 7) more than 3 months of Expected survival period 8) sufficient function of important organs O WBC: >= 4,000 and =< 12,000/mm3 O Neutrocyte: => 2,000/mm3 O Platelet: >= 100,000/mm3 O Hb: >= 9.0 g/dl O sGOT,sGPT: 2.5 times of normal range in each institute O sT.bil.: <= 1.5 mg/dl O sCreatinin: <= upper limit of each institute O Ccr from Cockcroft-Gault's method: >= 50 ml/min O ECG: normal range 9) written informed consent 10) patients who can take food orally
Exclusion criteria
Exclusion criteria: 1)Pulmonary fibrosis or Interstitial Pneumonitis by chet X-ray examination 2)Cavity fluid which needs drainage 3)with active double cancer 4)with peripheral nerve disorder 5)with intestinal paralysis or intestinal obstruction 6)under watery diarrhea 7)uncontrolled DM 8)with mental disorder which disturbs registration to this study 9)with infectious disease 10)patients who receive steroids treatment 11)Cardiac failure, liver dysfunction, or renal dysfunction which disturb Registration to this study 12)with brain metastasis and its symptom 13)pregnant women or women who like to be pregnant 14)history of severe allergy against drug 15)patients receiving Atazanabil 16)doctor's dicision not to be registered to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate(RECIST) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, Progression Free Survival, Adverse Events, Incidence of Recruitement | — |
Countries
Japan
Contacts
Public ContactFurukawa Hiroshi
Sakai City Hospital Director
Outcome results
None listed