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

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ClinicalTrials.gov Identifier: NCT03386825
Recruitment Status : Completed
First Posted : December 29, 2017
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Neoplasms Drug: Regorafenib (Stivarga, BAY73-4506)

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Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
Actual Study Start Date : January 31, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Regorafenib

Group/Cohort Intervention/treatment
Regorafenib_DoT<4 months
DoT < 4 months
Drug: Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)

Regorafenib_4 months ≤ DoT < 12 months
4 months ≤ DoT < 12 months
Drug: Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)

Regorafenib_DoT ≥ 12 months
DoT ≥ 12 months
Drug: Regorafenib (Stivarga, BAY73-4506)
Antineoplastic agents, protein kinase inhibitor (L01XE21)




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386825


Locations
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Belgium
Belgium
Multiple Locations, Belgium
Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03386825     History of Changes
Other Study ID Numbers: 19577
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Metastatic Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases