locally advanced rectal cancer
Conditions
Sponsors
Gastroenterological surgery, Hirosaki University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed Rectum adenocarcinoma 2) Adequate following in the diagnostic imaging within 28 days before registration -Clinical stage T3, any N, or T4, any N -Main lesion of the tumor is located at the Ra or Rb -The edge of tumor is lower than the peritoneal reflection -Not diffuse infiltrating carcinoma. 3) Without liver, peritoneum and distant metastases 4)Age of 20-80 years Possigle to R0 resection 5) without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy) 6)Aadequate function of important organs 1. WBC: >=3,000/mm3 and 12,000/mm3 2. Neutrophil: >=1,500/mm3 3. Platelet: >=100,000/mm3 4. Hemoglobin: >=9.0g/dL 5. AST, ALT: <100IU/L 6. T Bil: <=2.0mg/dL 7. Serum creatinine: <=1.2mg.DL 8. creatinin clearance level >= 60mi/min 7) ECG: without clinically problematic abnormalities within 28 days before registration 8) Eastern Cooperative Oncology Group performance status (PS) 0-1 9) With ability of oral intake 10) Written informed concent
Exclusion criteria
Exclusion criteria: 1) with gastrointestinal ulceration or bleeding 2) with sensory neuropathy 3) with severe diarrhea 4) had a previous serious drug allergies 5) had pleural effusion or ascites which need therapy 6) with brain metastasis or suspected the brain metastases 7) had surgery within 28 days before registration 8) had thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia 9) had serious complication (e.g. interstitialpneumonia, or pulmonary fibrosis, kidney injury, hepatic failure, uncontrolled diabetes mellitus, uncontrolled hypertension) 10) with active double cancer 11) had active infection disease (over 38.0 degree) 12) with significant abnormal electrocardiogram or cardiovascular disease (e.g. heart failure, myocardial infarction, angina pectoris) 13) receiving Flucytosine 14) pregnant or lactating women, women who are capable of pregnancy, intend to get pregnant or men who want to get their partners pregnant 15) were systemically-administered of steroids 16) with contraindications to TS-1 and L-OHP 17) with HBsAg-positive 18) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cumulative recal recurrence rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapse free survival, Overall survival, Treatment completion rate, Down-staging rate, Safety, sphincter-preservation rate, time from definite diagnosis to initiation of therapy | — |
Countries
Japan
Contacts
Public ContactHajime Morohashi
ACCS Hirosaki University Hospital
Outcome results
None listed