Trial Condition(s):
Colorectal Neoplasms
Metastatic Colorectal cancer patients with Long-term response to regorafenib (COLONG)
Bayer Identifier:
19577
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.
Inclusion Criteria
- Male or female patients ≥ 18 years of age. - Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July 2017. - Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options. - Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment. - Sufficient kidney, liver and bone marrow function start of Stivarga treatment. - Life expectancy ≥ 3 months at start of Stivarga treatment
Exclusion Criteria
- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Belgium many locations, Belgium | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
COLONG: Metastatic Colorectal cancer patients with Long-term response to regorafenib
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
3
Primary Outcome
- Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sampleTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- ECOG performance status (0, 1)ECOG: Eastern Cooperative Oncology GroupTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Primary site of diseaseRectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Tumor resection (yes, no, unknown)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Specific site of metastasisLung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, UnknownTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- KRAS mutation (yes, no, unknown)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- RAS mutation (yes, no, unknown)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- BRAF mutation (yes, no, unknown)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary Outcome
- Start date of Stivarga treatmentTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Reason for discontinuation of Stivarga treatmentprogression – symptomatic, Progression – radiological, Progression - radiological + symptomatic, Progression – unknown, Intolerability, Death, other, unknown, not applicableTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Subsequent mCRC treatmentChemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicableTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Last daily Stivarga dose80 mg, 120 mg, 160 mg, other, unknownTimeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Duration of treatment (months)Timeframe: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Additional Information
Not Available
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