Colorectal Neoplasms
Conditions
Keywords
Regorafenib, Colorectal Neoplasms
Brief summary
This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Regorafenib for colorectal cancer. The objective of this study is to assess safety and effectiveness of Regorafenib using in real clinical practice. A total of 1,250 patients are to be enrolled and assessed in 6 months standard observational period. At 12 months after the first administration of Regorafenib for confirmation of efficacy information including treatment duration and survival status of the patient.
Interventions
DRUGRegorafenib (Stivarga, BAY73-4506)
Patients treated with Regorafenib under practical manner for colorectal cancer.
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients * who are determined to start Regorafenib/ STIVARGA treatment
Exclusion criteria
* Patients who have previously received Regorafenib/ STIVARGA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse drug reactions (ADRs) from the first administration of regorafenib | Up to 6 months |
| Number of patients with serious adverse events(SAEs) from the first administration of regorafenib. | up to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 12 months | — |
| Overall survival in subpopulations | Up to 12 months | — |
| Number of pateints with ADRs in subpopulations | Up to 6 months | — |
| Time to Treatment failure in subpopulations | Up to 12 months | — |
| Tumor response assessed by RECIST or physicians own evaluation | Up to 6 months | RECIST: Response Evaluation Criteria In Solid Tumors |
| Time to treatment failure (TTF) | Up to 12 months | — |
| Number of patients with SAEs in supopulations | Up to 6 months | — |
Countries
Japan
Outcome results
None listed