Metastatic Colorectal CancerNCT02673710
A Study to Assess the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With Chemotherapy Combined With Bevacizumab
An observational study of Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 23 sites in Belgium.
Trial summary
The purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- How many people
- 200 participants
- Where
- 23 sitesBelgium
- Study dates
- 14 Mar 2016to 4 Feb 2020
- 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: Participants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing chemotherapy regimen (CTR) will be included in this study
Who may be able to join
- Patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond PD1.
- Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
- Availability of specific retrospective data at diagnosis and during 1st line treatment
Who cannot join
- Patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition
- Dementia or another mental condition making it impossible to fill out questionnaires
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Belgium23 sites
Onze Lieve Vrouwziekenhuis Aalst
Aalst, 9300
AZ Sint Lucas Brugge
Assebroek, 8310
CHIREC
Auderghem, 1160
Imeldaziekenhuis
Bonheiden, 2820
AZ KLINA
Brasschaat, 2930
AZ Sint Jan
Bruges, 8000
Institut Jules Bordet X
Brussels, 1000
Hospital Erasme
Brussels, 1070
Cliniques Universitaires St-Luc
Brussels, 1200
Grand Hôpital de Charleroi Notre Dame
Charleroi, 6000
AZ Maria Middelares
Ghent, 9000
Jessa Zkh (Campus Salvator)
Hasselt, 3500
UZ Leuven Gasthuisberg
Leuven, 3000
CHC MontLégia
Liège, 4000
CHU Sart-Tilman
Liège, 4000
AZ St Maarten Campus Leopoldstr
Mechelen, 2800
Hôpital André Vésale
Montigny-le-Tilleul, 6110
AZ Damiaan
Ostend, 8400
AZ Delta (Campus Wilgenstraat)
Roeselare, 8800
AZ Glorieux- vzw Werken Glorieux
Ronse, 9600
AZ Nikolaas (Sint Niklaas)
Sint-Niklaas, 9100
AZ Turnhout Sint Elisabeth
Turnhout, 2300
CHR de Verviers - East Belgium
Verviers, 4800
About this study
Official title: A Multicenter Non-Interventional Study Exploring the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With a Chemotherapy Combined With Bevacizumab
The purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- No intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Besides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling
| Study group | Role | What they receive |
|---|---|---|
| Participants with metastatic colorectal cancer | Participants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing CTR will be included in this study Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first
Measured: Up to 3 years
Sarcopenia quantified via CT-scan defined as a skeletal muscle index at the 3rd lumbar vertebra below 41 for women and below 43 or 53 for men with a Body Mass Index below or above 25 respectively
Measured: Up to 3 years
Secondary outcomes (26)
Participants body weight at initial diagnosis of mCRC
Measured: Up to 3 years
Participants body mass index at initial diagnosis of mCRC
Measured: Up to 3 years
Participants skeletal muscle mass at initial diagnosis of mCRC
Measured: Up to 3 years
Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE
Measured: Up to 3 years
Participants Eastern Cooperative Oncology Group Performance status at SE
Measured: Up to 3 years
Participant muscle strength at initial diagnosis of mCRC
Measured: Up to 3 years
Participants primary and metastases location at Initial Diagnosis
Measured: Up to 3 years
Participants mutation status at Initial Diagnosis
Measured: Up to 3 years
Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis
Measured: Up to 3 years
Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis
Measured: Up to 3 years
Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis
Measured: Up to 3 years
Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants
Measured: Up to 3 years
Participant Physical status expressed in muscle strength
Measured: Up to 3 years
Participant Physical status expressed in Body Weight
Measured: Up to 3 years
Participant Physical status expressed in Body Mass Index
Measured: Up to 3 years
Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire
Measured: Up to 3 years
Nutritional status using Visual Analogue Scale for appetite
Measured: Up to 3 years
Treatment related toxicity using MD Anderson Symptom Inventory scale
Measured: Up to 3 years
Number of participants with Number of chemotherapy cycles
Measured: Up to 3 years
Number of participants with Number of bevacizumab administrations
Measured: Up to 3 years
Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease
Measured: Up to 3 years
Number of participants with Reason for treatment changes
Measured: Up to 3 years
Intake dietary supplements
Measured: Up to 3 years
Dietary and physical counselling
Measured: Up to 3 years
Number of Participants with Adverse Events
Measured: Up to 3 years
First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study start14 Mar 2016
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673710
- Sponsor's protocol ID
- ML29985
- Status last verified
- Mar 2020
- First submitted
- 27 Jan 2016
- Last updated
- 25 Mar 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Non-Interventional Study Exploring the Impact of Sarcopenia on the Outcomes of Colorectal Cancer Patients Treated With a Chemotherapy Combined With Bevacizumab
- ClinicalTrials.gov ID
- NCT02673710
- Acronym / sponsor ID
- ML29985
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 4 Feb 2016 (estimated)
- 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 purpose of this study is to explore the relationship between sarcopenia, as defined by computed tomography, treatment related outcomes and other body composition related parameters in a patient population receiving bevacizumab beyond progression.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with metastatic colorectal cancer | – | Other: No interventionParticipants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing CTR will be included in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants diagnosed with mCRC treated in first line with a combination of bevacizumab and chemotherapy for whom it is decided to continue the administration of bevacizumab beyond progression while changing chemotherapy regimen (CTR) will be included in this study
Key inclusion criteria (3 listed)
- Patients treated in first line with bevacizumab for whom it is decided, and who are clinically considered eligible, to continue the treatment with bevacizumab beyond PD1.
- Women of childbearing potential have to use effective contraception during (and up to 6 months after) treatment.
- Availability of specific retrospective data at diagnosis and during 1st line treatment
Key exclusion criteria (2 listed)
- Patients who are participating or participated in first line in any other interventional clinical trial involving non-standard of care procedures impacting the body composition
- Dementia or another mental condition making it impossible to fill out questionnaires
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 |
|---|---|---|
| No interventionBesides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling | Other | Participants with metastatic colorectal cancer |
Primary outcome
Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first
Time frame: Up to 3 years
Sarcopenia quantified via CT-scan defined as a skeletal muscle index at the 3rd lumbar vertebra below 41 for women and below 43 or 53 for men with a Body Mass Index below or above 25 respectively
Time frame: Up to 3 years
26 secondary outcomes
Participants body weight at initial diagnosis of mCRC
Time frame: Up to 3 years
Participants body mass index at initial diagnosis of mCRC
Time frame: Up to 3 years
Participants skeletal muscle mass at initial diagnosis of mCRC
Time frame: Up to 3 years
Participants visceral fat mass, subcutaneous fat mass, total fat mass at SE
Time frame: Up to 3 years
Participants Eastern Cooperative Oncology Group Performance status at SE
Time frame: Up to 3 years
Participant muscle strength at initial diagnosis of mCRC
Time frame: Up to 3 years
Participants primary and metastases location at Initial Diagnosis
Time frame: Up to 3 years
Participants mutation status at Initial Diagnosis
Time frame: Up to 3 years
Participants C-Reactive Protein and Albumin blood values at Initial Diagnosis
Time frame: Up to 3 years
Participants Date of diagnosis of non-metastatic CRC disease at Initial Diagnosis
Time frame: Up to 3 years
Participant with 1st line Chemotherapeutic regimen at Initial Diagnosis
Time frame: Up to 3 years
Functional status using Functional Assessment for Cancer Treatment - specific for Colorectal cancer participants
Time frame: Up to 3 years
Participant Physical status expressed in muscle strength
Time frame: Up to 3 years
Participant Physical status expressed in Body Weight
Time frame: Up to 3 years
Participant Physical status expressed in Body Mass Index
Time frame: Up to 3 years
Nutritional status using the Patient-Generated Subjective Global Assessment questionnaire
Time frame: Up to 3 years
Nutritional status using Visual Analogue Scale for appetite
Time frame: Up to 3 years
Treatment related toxicity using MD Anderson Symptom Inventory scale
Time frame: Up to 3 years
Number of participants with Number of chemotherapy cycles
Time frame: Up to 3 years
Number of participants with Number of bevacizumab administrations
Time frame: Up to 3 years
Number of participants with Treatment changes and treatment (un)changed until Second Progressive Disease
Time frame: Up to 3 years
Number of participants with Reason for treatment changes
Time frame: Up to 3 years
Intake dietary supplements
Time frame: Up to 3 years
Dietary and physical counselling
Time frame: Up to 3 years
Number of Participants with Adverse Events
Time frame: Up to 3 years
First Progression Free Survival (PFS1) is defined as the time between initial diagnosis and first progressive disease
Time frame: Up to 3 years
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 25 Mar 2020.
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CRC
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.
Clinical Trials study director
Hoffmann-La Roche
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 23 sites 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 3 inclusion and 2 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 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Second Progression Free Survival (PFS2) defined as the time interval between study entry and the date of progression or death for any cause, whichever occurs first (time frame: Up to 3 years). The study lists 2 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 25 Mar 2020.