colon cancer
Conditions
Interventions
Treatment is administered every 3 weeks until evidence of progression, unacceptable toxicity, patient refusal, or for 4 cycles.
Sponsors
Sano HospitalGastrointestinal Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.colorectal cancer,cytologically and/or 2. synchronous or metachronous liver metastases *no prior treatment for liver metastases 3.no extra hepatic metastases 4.no prior treatment for liver metastasis 5.at least one or more measurable lesions of liver metastases 6.6 months or later after last dose of oxalipatin as adjuvant chemotherapy following primary resection 7.age: 20- years old 8.ECOG PS: 0-1 9.witten informed consents 10.sufficient organ functions
Exclusion criteria
Exclusion criteria: 1.clinical or radiological evidence of CNS metastases. 2. current or previous (within the last 1 year) history of cerebrovascular disease 3.major surgical procedure, open biopsy or significant traumatic injury except for CV-port procedure within 28 days prior to Day 0 4.serious non-healing fracture 5.current or previous (within the last 1 year) history of GI perforation 6.serious non-healing ulcer 7.evidence of bleeding diathesis or coagulopathy. 8.current or recent (within 10 days prior to enrllment) ongoing treatment with anticoagulants for therapeutic purposes 9.ongoing treatment with aspirin (> 325 mg/day) 10.clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction 11.uncontrolled hypertension 12. serious renal failure, 1+ or higher proteinuria within 2 weeks prior to enrollment 13.uncontrolled pleural and/or peritoneal effusion 14.past or current history (within the last 5 years) of malignancies except for the indication under this study and curatively treated: - Basal and squamous cell carcinoma of the skin - In-situ carcinoma of the cervix 15.interstitial lung disease, or pulmonary fibrosis 16.uncontrolled infection 17.history of organ 18. diarrhea >= Grade 2 according to the Common Toxicity Criteria of the National Cancer Institute, version 3. 19.pregnancy (positive serum pregnancy test) and lactation 20.serious drug hypersensitivity or a history of drug allergy 21.history of adverse events related to fluorouracil 22.with liver cirrhosis and/or Viral hepatitis 23.Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| response ratetumor regression grade1-3.Tumor Regression Grade1-3.progression-free survival.relapse-free survival.R0 liver resection rate.adverse events.postoperative complications.sinusoidal dilatation.ICG R15 fluctuation.sub-group analysis by Kras mutational status | — |
Countries
Japan
Contacts
Public ContactHiroki Hashida
Kobe City Medical Center General Hospital Surgery
Outcome results
None listed