rectal cancer
Conditions
Interventions
TS-1:Level1 50mg/m2, Level2 65mg/m2,Level3 80mg/m2 day1-5,8-12,15-19,22-26,29-33 Radiation:1.8Gy of consecutive 5days, Total dose 45 Gy
Sponsors
Toho University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed low Rectum adenocarcinoma(without Rs) 2.Preoperative CT or MRI findings the clinical stage is T3-4 and any N 3.Main lesion of the tumor is located at the Ra or Rb. 4.Recectable 5.No evidence of peritoneal metastasis, liver metastasis and distant metastasis. 6.age:20-80years old 7.Performance status 0-1 8.Without prior anti-tumor therapy 9. Adequate organ function 10.the case can eat 11.Written IC
Exclusion criteria
Exclusion criteria: 1.Impossible to receive TS-1 contained chemotherapy 2.Recieving the radiation therapy in a pelvis 3.Infection 4.Serious complications 5.Myocardial infarction within the last 6 months, previous serious medical illness or allergy for drug 6.Multiple malignancies 7. Pleural effusion or ascites requiring 8.Current or previous Brain metastasis 9.Diarrhea(watery stool) 10.Fresh bleeding of digestive organs 11.Need to treatment with flucytosine, atazanavir sulfate, or warfalin 12.Evidence of psychiatric disability interfering with enrollment to clinical trial 13.Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant 14.Man of wanting child 15.Need Systemically administration of corticosteroids 16.Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose Recommended dose | — |
Countries
Japan
Contacts
Public ContactKimihiko Funahashi
Toho University School of Medicine Division of general and gastroenterological surgery, Department of Surgery (Omori)
Outcome results
None listed