Colorectal Neoplasm
Conditions
Brief summary
The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
Interventions
DRUGRegorafenib (Stivarga, BAY 73-4506)
As determined by the treating physician
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
´ * Male or female patients ≥ 18 years of age with metastatic CRC for whom the decision has been taken by the investigator to treat with Stivarga. * Patients must have signed an informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | after 40 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | after 40 months | — |
| Disease control rate (DCR) | after 40 months | Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease). |
| Progression-free survival | after 40 months | — |
| Tumor status at different visits | after 40 months | The tumor status at different visits will be evaluated according to the categories complete response, partial response, stable disease, progressive disease by clinical judgment, progressive disease measurement proven, unknown and not applicable. The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories. |
| Incidence of treatment emergent adverse events (TEAE) | after 18 and 40 months | Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug. |
| Duration of Stivarga treatment | after 40 months | Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation) |
Countries
Germany
Outcome results
None listed