Rectal Cancer
Conditions
Interventions
Chemotherapy: UFT:240, 300 mg/m2/day LV:75 mg/body/day Day 1-28 Radiotherapy: 1.8 Gy/day, Day 1-5 every 7 days, 25 times, total 45Gy
Sponsors
Division of Gastrointestinal Surgery, Kobe University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The case of T3 and T2N1-2 rectum cancer proved for histopathology (Besides Rs) (2) The first time chemotherapy case (3) The case without the past of the radiation therapy (4) The case without the high obstacle for the marrow, the liver, the kidney and cardiac function(judging from the laboratory data within 14 days before registration) (5) The case without the ileus (6) The case performance status (ECOG) is 0-1 (7) The case that survival time is expected to be more than three months from a treatment start day (8) Age at the time of the consent acquisition is over 20 years old. (9) Written informed consent
Exclusion criteria
Exclusion criteria: (1) The case with a serious myelosuppression (2) The case that it is clear to have pneumonitis, pulmonary fibrosis with a chest x-ray film, or the case having these anamneses (3) The pleural or pericardial effusion requiring drainage (The case to need tube drainage or waste fluid by the puncture) (4) The case with the double cancer (The cancer in the epithelium and the skin cancer are removed.) (5) The infectious disease, the intestinal paralysis and the ileus (6) Diarrhea (water-like mail) (7) It is during treatment or a control poor diabetes case by continuous use of the insulin (8) The case having a complication (heart failure, liver failure, renal failure) (9) The brain metastasis case of the existence symptom (10) The pregnant or nursing patients and patients who may be a pregnant (11) The case with having experienced serious drug allergy in the past (12) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decision of maximal tolerated dose (MTD) and recommended dose (RD) of UFT Safety (the degree and grade of the adverse event and the surgical complication) | — |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor effect (objective response rate) The rate of pathological CR | — |
Countries
Japan
Contacts
Public ContactTakashi Kamigaki
Kobe University Graduate School of Medicine Division of Gastrointestinal Surgery
Outcome results
None listed