check_circleStudy Completed

Colorectal neoplasms

Bayer Identifier:

17816

ClinicalTrials.gov Identifier:

NCT02347852

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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


  • - Subjects unwilling to complete all questionnaires involved in the local OS
    - Subjects unwilling to wear the pedometer

Trial summary

Enrollment Goal
25
Trial Dates
January 2015 - September 2016
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum Kreuzschwestern Wels GmbHMany Locations, 4600, Austria

Primary Outcome

  • Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaire
    date_rangeTime Frame:
    At 3 months
    enhanced_encryption
    Safety Issue:
    No

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 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 months
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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