NCT02347852

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
29 days until next milestone

Study Start

First participant enrolled

January 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2016

Completed
Last Updated

September 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

December 22, 2014

Last Update Submit

September 7, 2018

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaire

    At 3 months

Secondary Outcomes (5)

  • 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 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 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

Study Arms (1)

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.

Drug: Regorafenib (Stivarga, BAY73-4506)

Interventions

Regorafenib (Stivarga, BAY73-4506)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.

Physical activity / Cohort 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants of NIS CORRELATE (NCT02042144, Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings) in Austria

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Kreuzschwestern Wels GmbH

Multiple Locations, 4600, Austria

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

January 27, 2015

Study Start

January 20, 2015

Primary Completion

September 8, 2016

Study Completion

September 8, 2016

Last Updated

September 10, 2018

Record last verified: 2018-08

Locations

AU(1)