rectal cancer
Conditions
Interventions
S-1 80 mg/m2 p.o. (day1-14) L-OHP 130 mg/m2(day 1) to be repeated every 3 week until 4 course or to meet discontinuation criteria
5-FU/bolus 400mg/m2 (day 1), 5-FU/continuous2,400 mg/m2 (day 1-2),
Sponsors
Kyushu Study group of Clinical Cancer(KSCC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Written informed consent 2) Patients who are judged to be suitable for receiving this protocol therapy by physician 3) Distal border of tumor is located under the peritoneal reflection 4)Histologically confirmed rectal adenocarcinoma 5) previously untreated rectal cancer 6) Within 28 days before registration, the tumor is considered by the surgeon to be amenable to curative resection [T category: cSS and cSE, cSI, cA, cAI. N category:cN0-2 and cN3(#253 lymph node)] 7) Within 28 days before registration, there is no evidence of distant metastasis by contrast- enhanced CT 8) >= 20 years old 9) PS(ECOG) 0-1 10) be able to take oral drugs 11) Required baseline laboratory parameters (within 14 days before registration): WBC >= 3000 ,<12000/mm3 Neu >= 1,500/ mm3 Hb >= 9.0g/dl Plt >= 100,000/ mm3 T-Bil <= 2.0mg/dl AST,ALT <= 100U/L Cre <1.5mg/dl Ccr >= 60mL/min 12) Considered to survive for more than 3 months.
Exclusion criteria
Exclusion criteria: 1) History of serious drug hypersensitivity or a history of drug allergy 2) Pregnant or lactating woman and man who hope for Partner's pregnant 3) Active infection(over 38 degree) 4) Blood transfusion within 14 days before registration 5) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, serious diabetes, serious hypertension) 6) Clinically significant abnormal electrocardiogram or heart disease 7) Serious diarrhea 8) Pleural effusion, peritoneal fluid that needs treatment 9) Previous history of serious lung disorder ( ex. interstitial lung disease or fibrosis, serious emphysema ) 10) Hemorrhagic diathesis, coagulation disorder 11) Active double cancer (synchronous double cancer or asynchronous double cancer with disease-free duration of 5 years or less). 12) Patients who need flucytosine, phenytoin or warfarin potassium. 13) Requiring steroid drug 14) Patients with contraindication to therapy 15) History of allergy to contrast material 16) Serious stricture (exclude the patients who are put in stoma) 17) Positive for HBs antigen and HCV antibody 18) Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-years Disease free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological Effect R0 resection rate Completion rate of each modality(Neoadjuvant chemotherapy, Operation and Adjuvant chemotherapy) Overall survival(OS) Disease Free survival(DFS) OS in patients with R0 resection DFS in patients with R0 resection Transition rate to Operation local recurrence rate(per Operated population) Safety Pattern of first recurrence | — |
Countries
Japan
Contacts
Public ContactKSCC
Clinical Research Support Center Kyushu KSCC
Outcome results
None listed