colorecal cancer
Conditions
Sponsors
Morohashi Hajime
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Hitologically confirmed colon or rectal cancer 2) With priary lesion on colon or rectal cancer 3) With primary and synchronous liver metastasis without other metastasis 4) With evaluable lesion 5) Where a surgeon judged hepatectomy is possible. As a measure of initially unresectable liver metastasis, it is assumed that the residual liver volume after hepatectomy is expected to be less than 30% even by portal vein embolism 6) Without extrahepatic lesions other than the primary lesion 1. Without pulmpnary metastasis by X-P or CT 2. Without hepatic and paraaortic lymph node swelling by CT 7) Age of 20-75 years 8) Without prior anti-tumor therapy (radiation therapy, chemotherapy and hormone therapy) 9) 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: = 60mi/min 9. Urine protein<=1+ 10. INR<=1.5 10) ECG: without clinically problematic abnormalities within 28 days before registration 11) Eastern Cooperative Oncology Group performance status (PS) 0-1 12) With ability of oral intake 13) Established stoma because of a primary lesion accompanied with high stenosis that does not allow the endoscope to pass 14) 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 |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, Relapse-free survival, R0 rate of primary tumor, R0 rate of liver metastasis, Reoperation rate, Completion rate of S-1 + oxaliplatin + bevacizumab, Safety, Efficacy | — |
Contacts
Public ContactHajime Morohashi
Hirosaki University Hospital
Outcome results
None listed