Rectal cancer
Conditions
Interventions
Adjuvant chemotherapy with oxaliplatin plus capecitabine
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically or cytologically confirmed colorectal cancer 2) High-risk stage II or stage III rectal cancer 3) Curability A surgery (no residual tumor visible to macroscopically and/or microscopically) 4) Age >= 20 years 5) ECOG performance status of 0-1 6) Patient of possible oral ingestion 7) No prior chemotherapy or radiotherapy 8) Able to start within 8 weeks after surgery 9) Adequate organ function 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Postoperative complications 2) Active double cancer 3) Severe neuropathy or sensory dysfunction. 4) Women who are pregnant or breast-feeding 5) Serious drug allergy 6) Clinically significant infectious disease 7) Clinically significant psychological disease 8) Patient who has any of the following complications i) Uncontrolled diabetes mellitus ii) Uncontrolled hypertension iii) Interstitial pneumonitis,lung fibrosis iv) Ileus or bowel obstruction v) Clinically significant heart disease 9) Other reasons for being unfit for the study as determined by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year overall survival rate safety, completion rate, relative dose intensity | — |
Countries
Japan
Contacts
Public ContactTsunekazu Mizushima
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed