Trial Condition(s):
Colorectal Neoplasm
Investigating the use of regorafenib (Stivarga®) in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy (RECORA)
Bayer Identifier:
16665
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Germany | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Trial Design
RECORA- Regorafenib in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Overall survivalTimeframe: after 40 months
Secondary Outcome
- Progression-free survivalTimeframe: after 40 months
- Time to progressionTimeframe: after 40 months
- Disease control rate (DCR)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).Timeframe: after 40 months
- Duration of Stivarga treatmentDuration 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)Timeframe: after 40 months
- Tumor status at different visitsThe 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.Timeframe: after 40 months
- Incidence of treatment emergent adverse events (TEAE)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.Timeframe: after 18 and 40 months
Additional Information
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