Colorectal Cancer
Conditions
Interventions
None listed
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following metastatic colorectal cancer patients, who had ECOG-PS 0 or 1, treated with regorafenib from Mar 25, 2013 (approval date in Japan) to May 31, 2016. 1. Patients with pulmonary or hepatic metastasis. 2. Patients who receives regorafenib at an initial dose of more than 120mg. 3. Patients whose administration duration of regorafenib excluding interruption is more than 35 days until initial CT from the start of regorafenib administration. 4. Patients who have CT imaged before and after administration in the same site. 5. Patients whose CT was imaged within 28 days before regorafenib administration. 6. Patients whose CT was imaged within 8 -12 weeks after regorafenib administration.
Exclusion criteria
Exclusion criteria: 1. Patients with active double cancer. Carcinoma in situ (intraepithelial carcinoma) or the intramucosal carcinoma equivalent lesion which are concurrent double cancers and heterochronous double cancers within five years of progression free, and the investigator judged to cure by topical treatment, are excluded as the double cancer. 2. Any other patients who are regarded as unsuitable for this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We evaluate the radiological changes in pulmonary and hepatic metastatic lesion using CT images scanned within 28 days before regorafenib administration and from 8 weeks to 12 weeks after the administration, and investigate the correlation with prognosis (PFS, OF). | — |
Secondary
| Measure | Time frame |
|---|---|
| Subset analysis of each pulmonary and hepatic metastasis in primary endpoint Drug exposure (initial dose, duration and relative dose intensity.) Overall survival Progression free survival (according to investigator assessment including clinical progression) Overall response rate Disease control rate Time to treatment failure Regorafenib related adverse event | — |
Countries
Japan
Contacts
Public ContactKSCC Research Secretariat
Clinical Research Support Center Kyushu KSCC Research Secretariat
Outcome results
None listed