Trial Condition(s):
Colorectal Neoplasms
Assessment of physical activity during therapy with regorafenib for metastatic colorectal cancer (REGO-ACT)
Bayer Identifier:
17816
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
- Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator’s routine treatment practice to prescribe regorafenib. - Patients enrolled in NIS CORRELATE in Austria - Signed patient informed consent for local OS
Exclusion Criteria
- Subjects unwilling to complete all questionnaires involved in the local OS - Subjects unwilling to wear the pedometer
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Klinikum Kreuzschwestern Wels GmbH Many Locations, Austria, 4600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Assessment of physical activity during therapy with regorafenib for metastatic colorectal cancer
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaireTimeframe: At 3 months
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’)Timeframe: At 3 months
- Relation of the amount of physical activity to fatigue data assessed in CORRELATE (NCT02042144, ‘Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings’)Timeframe: At 3 months
- 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’)Timeframe: At 3 months
- 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’)Timeframe: At 3 months
- 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’)Timeframe: At 3 months
Additional Information
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