Locally advanced low rectal cancer
Conditions
Interventions
a. Xeloda 1700 mg/m2/Day b. UFT 300mg/m2/Day USEL 75mg/body/Day c. Radiation Therapy 50GY 2x25 times
Sponsors
Gunma University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age over 20 and under 80 2.Performance Status 0-2 3.Adenocarcinoma in pathological diagnosis 4.Rectal cancer reached the area of Rb. 5.Tumor progression is T3 or N positive. Alternatively, it should be T2 which is difficult to treat with anus-conserving surgery. 6.A minor axis 8mm is positive with a decision of lymph node metastasis 7. Vital organ functions (listed below) are preserved. 1) WBC>=4,000/ul and WBC<12,000u/l 2) Platelet>100,000/ul 3) GOT and GPT: under 2.5x upper limit of normal. 4) T-Bil<=1.5mg/dL 5) BUN<=25mg/dL 6) Cr<=1.5mg/dL 7) Normal ECG (clinically qualified with an irregular pulse and ischemic change) 8. Patients who have not previously treated with rectal cancer 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Distant metastasis or inguinal lymph node metastasis is positive 2. Serious organ derangement 3.Patient with ascetic fluid and pleural effusion which are needed a drainage 4. Patient with constant bleeding from the alimentary canal 5. Patient with active infection 6. Patient with serious disease condition (paresis of intestine, interstitial pneumonia, intestinal blockage, diabetes mellitus, etc) 7. Patient with active double cancer. (Exclude disease free interval over 5 years) 8. Patient has ventral pre-existing in radiation therapy 9. Patient with impaired mental status. 10. Pregnancy 11. Other ineligible status judged by attending doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological local effect | — |
Countries
Japan
Contacts
Public ContactTakayuki Asao
Gunma University Graduate School of Medicine Department of Oncology Clinical Development
Outcome results
None listed