Rectal cancer
Conditions
Interventions
Radiation2.0 Gy/day 25 times (5 weeks), total radiation 50Gy. Consisting of 5 weeks and 5 consecutive days of radiation followed by 2 days off. UFT 300mg/m2 and LV 75mg/day orally daily on days 1-5 re
Sponsors
Saitama Medical Center, Saitama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age:20-75 years old 2. Performance status(ECOG):0-2 3. Histopathological confirmation of wel or mod adenocarcinoma 4. The main site the tumor is occupying is Ra or Rb 5. No metastasis of lymph node without region lymph node 6. Sufficient organs functions 7. No prior treatment for rectal cancer 8. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with severe organ disfunction 2. Patients with uncontrollable ascites and pleural effusion 3. Patients with gastrointestinal bleeding 4. Patients with severe infection 5. Patients with severe complications 6. Synchronous or metachronous malignancy 7. Patients who have undergone abdominal radiotherapy 8. Patients with severe mental disorders 9. Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. 10. Any other cases who are regarded as inadequate for study enrollmet by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accomplishment rate of sphincter-preserving surgery with mesorectal excision. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of adverse events, surgical morbidity and mortality and postoperative QOL. 2. Macroscopic and pathological evaluation of primary lesion 3. Histological change of normal tissue in resected specimen 4. Disease free survival (DFS) and overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactHideyuki Ishida
Saitama Medical Center, Saitama Medical University Department of Digestive Tract and General Surgery
Outcome results
None listed