Assessment of Physical Activity During Therapy With Regorafenib for Metastatic Colorectal Cancer (REGO-ACT)

Bayer

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Observational

Funder types: Industry

Identifiers

NCT02347852

SV1415AT (Other Identifier)

17816

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

25 participants in 1 patient group

Physical activity / Cohort 1

Description:

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.

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)