colorecrtal cancer
Conditions
Interventions
UFT capsule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).
UFT E-granule / LV for 28 days with 7 days rest for 180days (6months)(1 course=5weeks, 35days).
Sponsors
HORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed Colorectal cancer 2)high-risk Stage II-III 3) Performance Status (ECOG) 0-1 4) more than 20 years old 5) hasn't received any treatment other than R0 resection. 6) can start the therapy within 8 weeks after surgery. 7) Adequate organ functions 8) Oral intake is possible 9) Written informed consent
Exclusion criteria
Exclusion criteria: A patient: 1)with administration contraindications for UFT,LV. 2)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years). 3)has severe postoperative complications such as serious postoperative infectious disease,anastomotic leak and gastrointestinal bleeding. 4) has severe diarrhea. 5)has severe drug hypersensitivity. 6)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant. 7)with psychosis or psychoneurosis. 8)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment complete rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Dose Intensity, QOL(EORTC QLQ-C30), Relapse free survival,overall survival | — |
Countries
Japan
Contacts
Public ContactKiyotaka Kurachi
Hamamatsu University School of Medicine Second Department of Surgery
Outcome results
None listed