Rectal cancer
Conditions
Interventions
preoperative FOLFOXIRI+surgery
preoperative chemoradiotherapy+surgery
Sponsors
Osaka Medical College Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pathologically proven adenocarcinoma. 2. Primary tumor located at Rectosigmoid, Upper rectum, Lower rectum, and Anal canal.The lower border of the tumor located between the peritoneal reflection and the anal verge. 3. cT3and cT4a tumor on contrast-enhanced CT or MRI 4. Lateral lymph nodes without 7mm and more in short axis diameter on contrast-enhanced CT or MRI data of 5mm-thickness slices (cN0-cN2) . 5. No distant metastasis on contrast-enhanced CT or MRI (cM0) 6. Aged 20 to 74 years old 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 8. Adequate organ function as evidenced by the following laboratory studies within 14 days prior to enrollment 1) Neutrophil count >= 1,500 /mm3 2) Platelet count >= 100,000 /mm3 3) Hemoglobin >= 9.0 g/dL 4) T.Bil =< 2.0 mg/dL 5) AST =< 100 IU/L, ALT =< 100 IU/L 6) Cr =< 1.5 mg/dL 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Currently treated with systemic steroids or immunosuppressive agent 2. Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ or mucosal carcinoma 3. Infectious disease to be treated 4. Positive for HBs antigen 5. Uncontrollable hypertension, Uncontrollable diabetes mellitus, Uncontrollable arrhythmia, and severe clinical problem 6. Grade 1 or more peripheral neuropathy 7. Women during pregnancy, possible pregnancy or breast-feeding 8. Severe mental disease 9. Attending physician determines that the case was inappropriate as the subject of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RFS:3 years relapse free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, Proportion of patients with R0 resection, Pathological response, 3 years progression free survival, 3 years overall survival, Incidence of adverse events, Proportion of operative complication, Proportion of anus-preservation without stoma, Evaluation of anal function, Evaluation of bladder function | — |
Countries
Japan
Contacts
Public ContactKeitarou Tanaka
Osaka Medical College Hospital Department of general and gastroenterological surgery
Outcome results
None listed