An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 5 sites in Serbia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
How many people: 191 participants
Where: 5 sitesSerbia
Study dates: Mar 2009to Aug 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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: Patients with metastatic colorectal cancer initiated on Avastin in combination with chemotherapy

Who may be able to join

Adult patients, >/= 18 years of age
Metastatic colorectal cancer
Prescribed to receive Avastin according to registered indication

Who cannot join

Patients not eligible for Avastin treatment according to the Summary of Product Characteristics

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Serbia5 sites

Study site
Belgrade, 11000
Study site
Belgrade, 11080
Study site
Kamenitz, 21204
Study site
Kragujevac, 34000
Study site
Niš, 18000

Other trials in Serbia

About this study

Conditions: 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.

Study groups in NCT01697449
Study group	Role	What they receive
Cohort		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With At Least One Adverse Event (AE)
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Measured: Up to 65 months

Secondary outcomes (4)

Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Measured: Up to 65 months
Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
Measured: Up to 65 months
Percentage of Participants With Disease Progression or Death
Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Measured: Up to 65 months
Progression Free Survival (PFS)
PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.
Measured: Up to 65 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Aug 2014

First posted2 Oct 2012 (estimated)
Study startMar 2009
Primary completionAug 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Prospective
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01697449
Sponsor's protocol ID: ML21889
Status last verified: Sep 2015
First submitted: 28 Sep 2012
Last updated: 16 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
ClinicalTrials.gov ID: NCT01697449
Acronym / sponsor ID: ML21889
Conditions: Colorectal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 2 Oct 2012 (estimated)
Results: Posted 16 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with metastatic colorectal cancer initiated on Avastin in combination with chemotherapy

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Metastatic colorectal cancer
Prescribed to receive Avastin according to registered indication

Key exclusion criteria (1 listed)

Patients not eligible for Avastin treatment according to the Summary of Product Characteristics

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With At Least One Adverse Event (AE)
Time frame: Up to 65 months
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

4 secondary outcomes

Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 65 months
Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline
Time frame: Up to 65 months
Percentage of Participants With Disease Progression or Death
Time frame: Up to 65 months
Progression Free Survival (PFS)
Time frame: Up to 65 months

Results and safety

Results posted to the registry on 16 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Colorectal Cancer (CRC) Cohort	191	101

Primary outcome: Percentage of Participants With At Least One Adverse Event (AE)

Time frame: Up to 65 months. Number. Unit: percentage of participants

Measure	CRC Cohort n = 191
Value	15.2

Population analysed: All participants who received at least 1 dose of study drug and underwent subsequent safety assessment were considered for the safety analysis.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 65 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CRC Cohort	23 of 191 (12%)	9 of 191 (4.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Colorectal Cancer

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
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Colorectal Cancer

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

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 5 sites in Serbia.

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 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 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Serbia. 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?

Yes. Results are posted in the registry (first posted 16 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With At Least One Adverse Event (AE) (time frame: Up to 65 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01697449.

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 16 Oct 2015.