Rectal cancers
Conditions
Interventions
Chemotherapy Surgery
Sponsors
Dept. Surgery Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Advanced lower rectal cancers with preoperative diagnosis as below: (a) T3 or resectable T4 of 5cm in minimal diameter (b) Massive lymph node metastases in the mesorectum (c) Metastatic lymph nodes located outside the pelvic plexus, along the internal iliac and common iliac vessels and in the obturator cavity 2) Performance status (ECOG): 0-1 3) Vital organ functions, including hematopoietic, cardiac, respiratory and renal functions, are preserved. 4) No evidence of distant metastases 5) No prior treatment histories of radiotherapy and/or chemotherapy for rectal cancers.
Exclusion criteria
Exclusion criteria: Excluded are cases with conditions as below: 1) Multiple malignancies to be treated. 2) Previous history of severe drug-induced allergy. 3) Active infectious diseases. 4) Coexistent severe diseases including pulmonary fibrosis, interstitial pneumonia, ileus, uncontrollable diabetes, cardiac dysfunction, hepatic failure, or renal failure. 5) Peritoneal or pleural fluid retention to be drainaged. 6) Symptomatic brain metastases. 7) Active digestive tract bleeding. 8) Severe watery diarrhea. 9) Pregnant. 10) Previous treatment history of radiotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year disease-free survival rates | — |
Countries
Japan
Outcome results
None listed