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Completed

NCT Number: NCT03386825

Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Belgium

Multiple Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

Antineoplastic agents, protein kinase inhibitor (L01XE21)

Primary outcomes

  1. Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  2. ECOG performance status (0, 1)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

    ECOG: Eastern Cooperative Oncology Group

  3. Primary site of disease

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

    Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)

  4. Tumor resection (yes, no, unknown)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  5. Specific site of metastasis

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

    Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown

  6. KRAS mutation (yes, no, unknown)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  7. RAS mutation (yes, no, unknown)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  8. BRAF mutation (yes, no, unknown)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Secondary outcomes

  1. Start date of Stivarga treatment

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  2. Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

  3. Reason for discontinuation of Stivarga treatment

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

    progression - symptomatic, Progression - radiological, Progression - radiological + symptomatic, Progression - unknown, Intolerability, Death, other, unknown, not applicable

  4. Subsequent mCRC treatment

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

    Chemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicable

  5. Last daily Stivarga dose

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

    80 mg, 120 mg, 160 mg, other, unknown

  6. Duration of treatment (months)

    Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: COLONG

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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