rectal cancer rectal cancer
Conditions
Interventions
S-1 is administered orally at 80mg/m2/day for 14 consecuitive days followed by a 7 day rest. L-OHP is given intravenously on days 1, at a dose of 130mg/m2/day. Bevacizumab is given intravenously on da
Chmotherapy
Sponsors
Miura Takuya
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=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: = 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Cumulative local recurrence rate, Relapse-free survival, Overall survival, pCR rate, N down-staging rate, Local response rate, mrTRG, Adverse event rate, Treatment-related death rate, Surgical complications rate, Organ sparing rate, R0 rate, The incidence of stoma dependence one year after operation | — |
Contacts
Public ContactTakuya Miura
Hirosaki University Graduate School of Medicine
Outcome results
None listed