Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer

Completed

• Conditions: Colorectal Neoplasms
• Interventions: Drug: Regorafenib (Stivarga, BAY73-4506)

• Registration Number: NCT02347852
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-22
• Study Start: 2015-01-20
• Study First Submitted QC: 2015-01-22
• Study First Posted: 2015-01-27
• Primary Completion: 2016-09-08
• Study Completion: 2016-09-08
• Status Verified: 2018-08
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Physical activity / Cohort 1	Regorafenib (Stivarga, BAY73-4506)	The non influenced and non triggered habitual physical activity of patients will be assessed by pedometer and physical activity questionnaire. The study population will consist of patients with metastatic CRC (mCRC) who are included in the NIS CORRELATE, have been previously treated with other approved regimens for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label prior to and independent of the inclusion into this observational study.

Primary Outcome Measures

Name	Time	Method
Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaire	At 3 months

Secondary Outcome Measures

Name	Time	Method
Relation of the amount of physical activity to fatigue data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings')	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')	At 3 months
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')	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')	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')	At 3 months

Trial Locations

Locations (1)

Klinikum Kreuzschwestern Wels GmbH; 🇦🇹 Multiple Locations, Austria