Colorectal NeoplasmsCOLONGNCT03386825
Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
An observational study of Colorectal Neoplasms, run by Bayer at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- How many people
- 76 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2018to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.
Who may be able to join
- 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
Who cannot join
- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COLONG: 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
- Keywords
- Metastatic Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (Stivarga, BAY73-4506)Drug
Antineoplastic agents, protein kinase inhibitor (L01XE21)
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib_DoT<4 months | DoT < 4 months Receives: Drug: Regorafenib (Stivarga, BAY73-4506) | |
| Regorafenib_4 months ≤ DoT < 12 months | 4 months ≤ DoT < 12 months Receives: Drug: Regorafenib (Stivarga, BAY73-4506) | |
| Regorafenib_DoT ≥ 12 months | DoT ≥ 12 months Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a DoT to Stivarga of more than 4 months versus total study sample
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG performance status (0, 1)
ECOG: Eastern Cooperative Oncology Group
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Primary site of disease
Rectum, Left-sided colon, Right-sided colon, Colon and rectum, Transverse, Unknown (in colon)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Tumor resection (yes, no, unknown)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Specific site of metastasis
Lung, Liver, Bone, Extraregional nodes, Peritoneum, Multiple, Unknown
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
KRAS mutation (yes, no, unknown)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
RAS mutation (yes, no, unknown)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
BRAF mutation (yes, no, unknown)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Secondary outcomes (6)
Start date of Stivarga treatment
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Number of prior treatment lines for metastatic cancer larger than 3 (yes, no, unknown)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Reason for discontinuation of Stivarga treatment
progression - symptomatic, Progression - radiological, Progression - radiological + symptomatic, Progression - unknown, Intolerability, Death, other, unknown, not applicable
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Subsequent mCRC treatment
Chemotherapy IV, Chemotherapy oral, Biologic therapy, Chemotherapy + biologic therapy, BSC, Other, Unknown, Not applicable
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Last daily Stivarga dose
80 mg, 120 mg, 160 mg, other, unknown
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Duration of treatment (months)
Measured: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start31 Jan 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386825
- Sponsor's protocol ID
- 19577
- Acronym
- COLONG
- Status last verified
- May 2018
- First submitted
- 22 Dec 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLONG: Metastatic Colorectal Cancer Patients With Long-term Response to Regorafenib
- ClinicalTrials.gov ID
- NCT03386825
- Acronym / sponsor ID
- COLONG / 19577
- Conditions
- Colorectal Neoplasms
- Keywords
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regorafenib_DoT<4 months | – | Drug: Regorafenib (Stivarga, BAY73-4506)DoT < 4 months |
| Regorafenib_4 months ≤ DoT < 12 months | – | Drug: Regorafenib (Stivarga, BAY73-4506)4 months ≤ DoT < 12 months |
| Regorafenib_DoT ≥ 12 months | – | Drug: Regorafenib (Stivarga, BAY73-4506)DoT ≥ 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Belgian mCRC patients who were treated with Stivarga between the 1st of July 2015 and 31 July 2017.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients participating in an investigational program/clinical trial with interventions outside of routine clinical practice during the observational period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)Antineoplastic agents, protein kinase inhibitor (L01XE21) | Drug | Regorafenib_4 months ≤ DoT < 12 months, Regorafenib_DoT ≥ 12 months, Regorafenib_DoT<4 months |
Primary outcome
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
ECOG performance status (0, 1)
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
ECOG: Eastern Cooperative Oncology Group
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)
Tumor resection (yes, no, unknown)
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
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
KRAS mutation (yes, no, unknown)
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
RAS mutation (yes, no, unknown)
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
BRAF mutation (yes, no, unknown)
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
6 secondary outcomes
Start date of Stivarga treatment
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
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
Reason for discontinuation of Stivarga treatment
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Subsequent mCRC treatment
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Last daily Stivarga dose
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Duration of treatment (months)
Time frame: Retrospective chart review from 1-Jul-2015 to 1-Dec-2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Bayer at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.