Overview

This trial is active, not recruiting.

Condition colorectal neoplasms
Treatment regorafenib (stivarga, bay73-4506)
Sponsor Bayer
Start date January 2015
End date October 2016
Trial size 25 participants
Trial identifier NCT02347852, 17816, SV1415AT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
regorafenib (stivarga, bay73-4506)
Stivarga is available as tablets (40 mg). It is taken in four-week treatment cycles at a recommended starting dose of 160 mg once every day for three weeks, followed by a week off.

Primary Outcomes

Measure
Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaire
time frame: At 3 months

Secondary Outcomes

Measure
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')
time frame: 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')
time frame: 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')
time frame: 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')
time frame: 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')
time frame: At 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Bayer.