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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-20

Study Completion Date

2016-09-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Physical activity / Cohort 1

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)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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