Metastatic colorectal cancer
Conditions
Interventions
Reduce the regorafenib toxicities
Sponsors
Shizuoka General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age > and 18 years old 2) Histological proven colon carcinoma 3) Patients had to have received standard therapies(fl uoropyrimidine,oxaliplatin, irinotecan, and bevacizumab;and cetuximab or panitumumab for patients who had KRAS wild-type tumours) and to have disease progression. 4) There is not adaptation of the radical operation. 5) ECOG-PS: 0 or 1 6) Patients want to be treated with regorafenib. 7) No prior treatment of regorafenib 8) No severe skin toxicity 9) life expectancy of at least 12 weeks 10) Adequate organ functions defined as indicated below (1)neutrophil >= 1,500 /mm3 (2)Plt >= 100,000 /mm3 (3) T.Bil <= 1.5 mg/dL (4) AST(GOT) , ALT(GPT) <= 100 IU/L (5) Cr < 1.5 mg/dL (6) Urine protein <= 2+ 11) Written informed consent
Exclusion criteria
Exclusion criteria: 1) No Hepatitis virus infection 2) No liver cirrhosis 3) No use of warfarin regularly 4) Patient with active double cancer (synchronous double cancer and metachronous double cancer), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 5) No chronic infection 6) Patient with severe complications, such as paralytic ileus, bowel obstruction, interstitial pneumonitis, pulmonary fibrosis, or uncontrollable diabetes mellitus, arrhythmias, heart failure, liver cirrhosis, and active hepatitis) 7) Pregnant or nursing patient or with intent to bear baby 8) Exclude the patients who are recognized as inadequate patients by doctors with responsibility in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduce the regorafenib toxicities by multidisciplinary team approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Toxicities 2) Dose intensity 3) Response rate, Progression-free survival | — |
Countries
Japan
Contacts
Public ContactKeisei Taku
Shizuoka General Hospital Division of Medical Oncology
Outcome results
None listed