Rectal Cancer
Conditions
Interventions
Fluororacil / l-leucovorin plus oxaliplatin (mFOLFOX6)
Sponsors
Tokyo Women's Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Stage II / III rectal caner 2. Depth invasion: T3 or T4 3. No prior surgery for rectum 4. No prior chemotherapy for rectal cancer 5. No prior radiotherapy 6. Age: 20-80 7. Performance status(ECOG): 0-1 8. Adequate bone marrow, liver and renal functions 9. Patients who can perform an surgery for rectum 2-6 weeks after chemotherapy. 10. Written informed concent.
Exclusion criteria
Exclusion criteria: 1. Comorbidity of active double cancer 2. Peripheral sensory nerve disorder 3. Poor controled hypertension 4. Poor controled diabetes mellitus 5. Severe electrocardiographic abnormality or comorbidity of poor controled heart failure 6. Comorbidity of severe pulmonary diease (interstitial lung disease, pulmonary fibrosis, emphysema pulmonum and so on) 7. Poor controlled psychiatric disorder or history of central nervous system disorder 8. Watery diarrhea 9. Treated continuously with systemic steroids 10. Pregnant or lactating women or women childbearing potential 11. Any other cases who are regarded as inadequate for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative respose rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological evaluation, R0 resection rate, Pathological complete respose rate, Down stage rate, Adverse events, The percentage of patients who complete scheduled treatment, Incidence of surgical morbidity and mortality | — |
Countries
Japan
Contacts
Public ContactMichio Itabashi MD
FACT Investigator Group Tokyo Women's Medical University Hospital
Outcome results
None listed