check_circleStudy Completed
Colorectal neoplasms
Bayer Identifier:
17816
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Assessment of physical activity during therapy with regorafenib for metastatic colorectal cancer
Trial purpose
The purpose of this trial is to quantitatively assess the average amount of physical activity that patients are capable to perform while receiving regorafenib for the treatment of metastatic colorectal cancer. The assessment of this reference value, measured by CE (Conformité Européene)-certified pedometer and international physical activity questionnaire, will allow an estimation on the feasible amount of physical activity for patients in this therapeutic setting.
This study is available for patients who are included in the global non-interventional study CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients; NCT01843400) in Austria.
This study is available for patients who are included in the global non-interventional study CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients; NCT01843400) in Austria.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
25Trial Dates
January 2015 - September 2016Phase
N/ACould I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum Kreuzschwestern Wels GmbH | Many Locations, 4600, Austria |
Primary Outcome
- Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnairedate_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Relation of the amount of physical activity to QoL (Quality of Life) data assessed in CORRELATE (NCT02042144, ‘Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings’)date_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
- Relation of the amount of physical activity to fatigue data assessed in CORRELATE (NCT02042144, ‘Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings’)date_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
- Relation of the amount of physical activity to DCR (Disease Control Rate) data assessed in CORRELATE (NCT02042144, ‘Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings’)date_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
- Relation of the amount of physical activity to OS (Overall Survival) data assessed in CORRELATE (NCT02042144, ‘Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings’)date_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
- Relation of the amount of physical activity to PFS (Progression Free Survival) data assessed in CORRELATE (NCT02042144, ‘Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings’)date_rangeTime Frame:At 3 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A