StageII colorectal cancer
Conditions
Interventions
UFT/LV as postoperative adjuvant chemotherapy for the stage II colorectal cancer is tested as follows: one patient group for 28 days with 7 days rest (everyday medication) and another patient group fo
Sponsors
Japanese Foundation for Multidisciplinary Treatment of Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient: 1)with histologically confirmed colorectal cancer. 2)with histologically confirmed StageII(T3-4,N0,M0)(TNM classification,UICC,Vol.7,2009)colorectal cancer(which is C,A,T,D or S)and rectal cancer(which is only RS). 3)has at least one of the following factors -T4 -Perforation,Penetration -Poorly differentiated adenocarcinoma -Mucinous carcinoma -Lymph node dissection:less than 12 4)underwent R0 resection. 5)is at the age of 20 to 80 at the time of registration. 6)whose Performance status(ECOG)is 0 or 1. 7)hasn't received any treatment other than R0 resection. 8)can take drugs orally. 9)whose sufficient functions of main organ should be confirmed by the clinical test within 14 days before registration as follows: i)WBC:>=3,000/mm3,<12,000/mm3 ii)neutrophil:>=1,500/mm3 iii)blood platelet:>=100,000mm3 iv)hemoglobin:>=9.0g/dL v)total bilirubin:=2.0mg/dL vi)AST(GOT):<=100IU/L vii)ALT(GPT):<=100IU/L viii)Scr:<1.5mg/dL 10)can start the therapy within 8 weeks after surgery. 11)whose written consent is taken.
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 any of the following complications: i)Uncontrollable diabetes mellitus ii)Uncontrollable hypertension iii)liver cirrhosis,liver failure iv)renal failure v)interstitial pneumonitis,lung fibrosis or severe emphysema vi)active infection vii)heart failure within 6 months,myocardial infarction,AP or sever abnormality of ECG 5)has severe diarrhea. 6)has severe drug hypersensitivity. 7)is a pregnant woman or a woman suspected of being pregnant,or,is a man who hopes to make his partner pregnant. 8)with psychosis or psychoneurosis. 9)In case that the doctor judged that he/she is disqualified for the enrollment in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Adverse events, Investigation of the efficacy for UFT/LV and the prognosis by the presence of CEA mRNA-positive later than 24 hours after surgery. | — |
Countries
Japan
Outcome results
None listed