resectable StageII, III colorectal cancer
Conditions
Interventions
Tegafur/uracil with oral leucovorin(UFT/LV) UFT is administered orally at 300mg/m2/day with 75mg/day of oral leucovorin for 21 consecutive days followed by a 7 days rest.
Sponsors
Department of Surgery Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)with histologically confirmed StageII, III colorectal cancer 2)with histologically confirmed colorectal cancer. 3)underwent R0 resection. 4)is at the age of 20 to 80 at the time of registration. 5)whose Performance status(ECOG)is 0 or 1. 6)can take drugs orally 7)whose sufficient functions of main organ should be confirmed by the clinical test within 14 days before registration as follows: i)WBC:>=3,500/mm3,<12,000/mm3 ii)neutrophil:>=1,500/mm3 iii)hemoglobin:>=9.0g/dL iv)blood platelet:>=100,000mm3 v)total bilirubin:=2.0mg/dL vi)AST(GOT):<=100IU/L vii)Scr:<1.2mg/dL 8)can start the therapy within 8 weeks after surgery. 9)whose written consent is taken.
Exclusion criteria
Exclusion criteria: 1)with active synchronous or metachronous malignancy other than carcinoma in situ(within 5 years). (2)Synchronous or metachronous malignancy other than carcinoma in situ 3)has severe postoperative complications such as serious postoperative infectious disease,anastomotic leak and gastrointestinal bleeding. 4)has any of the following complications: i)Uncontrollable diabetes mellitus ii)Uncontrollable hypertension iii) heart failure within 6 months,myocardial infarction,AP or sever abnormality of ECG iv)renal failure v)interstitial pneumonitis,lung fibrosis or severe emphysema . 5)has any of the following : i)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant ii)nursing women 6)with psychosis or psychoneurosis. 7)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event 3-year Disease free survival ratio | — |
Countries
Japan
Contacts
Public ContactTsuyosi Okabayashi
Keio University School of Medicine Department of Surgery
Outcome results
None listed