Unresectable rectal cancer by organ-preserved TME
Conditions
Sponsors
Aomori Colorectal Cancer Study (ACCS) group
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 1. Clinical stage T3, any N, or T4, any N 2. The edge of tumor is lower than Ra, Rb, P (Within 12cm from anal verge) 3. Unresectable rectal cancer by organ-sparing TME which was judged by high resolutoin MRI -CRM<=1mm -T4b -Lateral lymph node metastasis 3) Without liver, peritoneum and distant metastases 4)Age of 15-75 years 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. T Bil: <=2.0mg/dL 6. AST, ALT: <100IU/L 7. Serum creatinine: <=1.2mg.DL 8. Creatinin clearance level >= 60mi/min 9. Urine protein<=1+ 10. INR<=1.5 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) had hemoptysis (2.5 ml or more of fresh blood) 16) had gastrointestinal perforation within 6 months 17) were systemically-administered of steroids 18) with contraindications to TS-1, L-OHP, and Bevacizumab 19) with HBsAg-positive 20) Physician will determine that the patient is inappropriate participate in this trail for the safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T down-staging rate | — |
Countries
Japan
Contacts
Public ContactTakuya Miura
Hirosaki University Graduate School of Medicine Gstroenterological Surgery
Outcome results
None listed