resectable T3 rectal cancer
Conditions
Interventions
Capecitabine: Treatment dose was decided by body mass index and prescribed day 1 to day 10 of continuous 10 days. Radiotherapy: A total dose of 25 Gy of radiotherapy was administered in 10 fraction
Sponsors
Meiwa Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed Rectum adenocarcinoma 2. Preoperative findings *The clinical stage is T3 and N0-2 *Main lesion of the tumor is located at the Rb *No extra mesorectal lymph node swelling (longest diameter is less than 8 mm) *Not type 4(Diffuse Infiltrative Type) 3. No evidence of peritoneal metastasis, liver metastasis and distant metastasis 4. Age:20-80years old 5. Without prior anti-tumor therapy 6. Adequate organ function 7. Normal ECG 8. Performance status 0-1 9. Oral intake possible 10.Written IC
Exclusion criteria
Exclusion criteria: 1.Previous history of severe drug-induced allergy 2.Multiple malignancies to be treated or synchronous colorectal cancer 3. Active infections 4. Serious complications 5.Previous history of Interstitial Pneumonitis 6.Pleural effusion or ascites requiring treatment. 7. Active digestive tract bleeding 8. Severe watery diarrhea 9. Pregnant or nursing 10.Systemic administration of corticosteroids 11. Patients of hepatitis B virus suface antigen positivity 12.Contraindication of S-1or CPT-11 13. Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor regression score Grade 2+3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety (rate of adverse events, rate of complication) Completion rate of preoperative chemoradiotherapy R0 resection rate Down-staging rate Down-sizing rate LFS; local recurrence free survival RFS; Recurrence free survival OS; Overall survival bowel, urinary and sexual function | — |
Countries
Japan
Contacts
Public ContactNaohito Beppu
Meiwa Hospital Surgery
Outcome results
None listed