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Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib (COLONG)

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Bayer

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Drug: Regorafenib (Stivarga, BAY73-4506)

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

The aim of this local NIS(Non-Interventional Study) is to determine the proportion of Belgian patients with a duration of treatment(DoT) to Stivarga of 4 months or more in relation to the total population of Belgian metastatic colorectal cancer(mCRC) patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017. In addition, this study aims to describe the clinical characteristics of Belgian patients with a short- or long-term DoT to Stivarga.

Enrollment

76 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female patients ≥ 18 years of age.
  • Patients who suffer from mCRC and who started treatment with Stivarga between the 1st of July 2015 and 31 July 2017.
  • Patients who already received alternative treatment options before Stivarga for the treatment of mCRC or who were not eligible for other treatment options.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1 at start of Stivarga treatment.
  • Sufficient kidney, liver and bone marrow function start of Stivarga treatment.
  • Life expectancy ≥ 3 months at start of Stivarga treatment

Exclusion criteria

  • Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.

Trial design

76 participants in 3 patient groups

Regorafenib_DoT<4 months
Description:
DoT \< 4 months
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)
Regorafenib_4 months ≤ DoT < 12 months
Description:
4 months ≤ DoT \< 12 months
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)
Regorafenib_DoT ≥ 12 months
Description:
DoT ≥ 12 months
Treatment:
Drug: Regorafenib (Stivarga, BAY73-4506)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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