check_circleStudy Completed
Colorectal Neoplasms
Bayer Identifier:
19577
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Metastatic Colorectal cancer patients with Long-term response to regorafenib
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
76Trial Dates
February 2018 - April 2018Phase
Phase 4Could I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Belgium | many locations, Belgium |
Primary Outcome
- Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sampledate_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- ECOG performance status (0, 1)ECOG: Eastern Cooperative Oncology Groupdate_rangeTime Frame: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)date_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Tumor resection (yes, no, unknown)date_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Specific site of metastasisLung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknowndate_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- KRAS mutation (yes, no, unknown)date_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- RAS mutation (yes, no, unknown)date_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- BRAF mutation (yes, no, unknown)date_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary Outcome
- Start date of Stivarga treatmentdate_rangeTime Frame: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)date_rangeTime Frame: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 applicabledate_rangeTime Frame: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 applicabledate_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Last daily Stivarga dose80 mg, 120 mg, 160 mg, other, unknowndate_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
- Duration of treatment (months)date_rangeTime Frame:Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A