Colon cancer
Conditions
Interventions
TS-1 is administered orally at a dose of 80 mg/m2/day b.i.d. for 28 days followed by 14 days of rest. Cycles are repeated every 6 weeks until 4 courses.
TS-1 is administered orally at a dose of 80 mg/
Sponsors
Nagoya Surgical Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histological proven stage III colon cancer or rectosigmoid cancer 2) Histologically confirmed adenocarcinoma of colorectal cancer 3) Curability A 4) Age: >=20 5) Performance Statues: 0-1(ECOG) 6) Without prior treatment except surgery 7) With ability of oral intake 8) Sufficient function of important organs within 14 days before the registration 9) With starting the treatment within 8 weeks after operation 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer 2) Synchronous or metachronous colorectal cancer 3) Severe postoperative complications 4) With following complications a) Uncontrollable diabetes mellitus b) Uncontrollable hypertension c) Mycardial infraction within 6 months d) Liver cirrhosis e) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema 5) Pregnant or nursing women, women who wish to become pregnant and men who are planning partners' pregnancy 6) History of mental disorder or treating it at the moment 7) Administration contraindication of TS-1 8) Continuous use of warfarin potassium 9) History of severe allergy 10) Not suitable for participation with any other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment completion rate, relative dose intensity, disease free survival, overall survival, safety | — |
Countries
Japan
Contacts
Public ContactKeisuke Uehara
Nagoya University Graduated School of Medicine Division of Surgical Oncology
Outcome results
None listed