An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 9 sites in Slovakia.

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 efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: Bevacizumab, Capecitabine and Oxaliplatin
How many people: 68 participants
Where: 9 sitesSlovakia
Study dates: Jul 2011to Feb 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: Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.

Who may be able to join

Adult patients, >/= 18 years of age
Metastatic colorectal cancer
Treatment in accordance with current Summary of Product Characteristics and local guidelines

Who cannot join

Contraindications according to current Summary of Product Characteristics and local guidelines

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Slovakia9 sites

Study site
Banská Bystrica, 975 17
Study site
Bratislava, 812 50
Study site
Bratislava, 833 10
Study site
Košice, 04001
Study site
Martin, 036 59
Study site
Nitra, 950 01
Study site
Poprad, 058 01
Study site
Prešov, 081 81
Study site
Ružomberok, 03426

Other trials in Slovakia

About this study

Official title: An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum

Conditions: Colorectal Cancer
Being tested: Bevacizumab, Capecitabine, Oxaliplatin
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BevacizumabBiological
Also called Avastin®
Bevacizumab administered according to prescribing information and normal clinical practice.
CapecitabineBiological
Also called Xeloda®
Capecitabine administered according to prescribing information and normal clinical practice.
OxaliplatinDrug
Also called Eloxatin™
Capecitabine administered according to prescribing information and normal clinical practice.

Study groups in NCT01399190
Study group	Role	What they receive
Bevacizumab		Participants will receive bevacizumab in combination with capecitabine and oxaliplatin. Receives: Biological: Bevacizumab; Biological: Capecitabine; Drug: Oxaliplatin

What is being measured

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

Progression-free Survival
Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.
Measured: From randomization to progression or death during the study (up to approximately 30 months)

Secondary outcomes (2)

Response Rate (Tumor Assessments According to RECIST)
Response to treatment (Response Rate) was defined as the percentage of participants with a complete remission (CR) or partial remission (PR), and was assessed by the investigators according to modified RECIST criteria. CR was defined as disappearance of all lesions. PR was defined as a decrease in sum of lesions size by more than 30%. Response Rate = CR +PR
Measured: Up to approximately 30 months
Percentage of Participants With Adverse Events
An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to approximately 30 months

Timeline

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

Jul 2011Feb 2014

First posted21 Jul 2011 (estimated)
Study startJul 2011
Primary completionFeb 2014
Study completionFeb 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: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01399190
Sponsor's protocol ID: ML25523
Status last verified: Aug 2016
First submitted: 20 Jul 2011
Last updated: 28 Sep 2016
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

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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Natural History Study of Early Life Exposures in Agriculture (ELEA)
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All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study of the Effect of First Line Treatment With Bevacizumab in Combination With Capecitabine and Oxaliplatin on Progression-free Survival in Patients With Metastatic Cancer of the Colon and Rectum
ClinicalTrials.gov ID: NCT01399190
Acronym / sponsor ID: ML25523
Conditions: Colorectal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Feb 2014 (actual)
Study completion: Feb 2014 (actual)
First posted: 21 Jul 2011 (estimated)
Results: Posted 28 Sep 2016

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
Bevacizumab	–	Biological: Bevacizumab, Biological: Capecitabine, Drug: OxaliplatinParticipants will receive bevacizumab in combination with capecitabine and oxaliplatin.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with colorectal cancer on first-line treatment with bevacizumab in combination with capecitabine and oxaliplatin.

Key inclusion criteria (3 listed)

Adult patients, >/= 18 years of age
Metastatic colorectal cancer
Treatment in accordance with current Summary of Product Characteristics and local guidelines

Key exclusion criteria (1 listed)

Contraindications according to current Summary of Product Characteristics and local guidelines

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
BevacizumabAlso: Avastin®Bevacizumab administered according to prescribing information and normal clinical practice.	Biological	Bevacizumab
CapecitabineAlso: Xeloda®Capecitabine administered according to prescribing information and normal clinical practice.	Biological	Bevacizumab
OxaliplatinAlso: Eloxatin™Capecitabine administered according to prescribing information and normal clinical practice.	Drug	Bevacizumab

Primary outcome

Progression-free Survival
Time frame: From randomization to progression or death during the study (up to approximately 30 months)
Progression-free survival was defined as the interval between the day of first treatment and the first documentation of disease progression or death and was assessed by the investigators according to modified Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was defined as an increase in sum of lesions size by more than 20% or new lesions.

2 secondary outcomes

Response Rate (Tumor Assessments According to RECIST)
Time frame: Up to approximately 30 months
Percentage of Participants With Adverse Events
Time frame: Up to approximately 30 months

Results and safety

Results posted to the registry on 28 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bevacizumab	68	48

Primary outcome: Progression-free Survival

Time frame: From randomization to progression or death during the study (up to approximately 30 months). Median (95% Confidence Interval). Unit: months

Measure	Bevacizumab n = 60
Value	7.000 (5.577 to 8.423)

Population analysed: Includes enrolled participants who were evaluable for the primary endpoint analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to approximately 30 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bevacizumab	2 of 63 (3.2%)	39 of 63 (61.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
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

9 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 9 sites in Slovakia.

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 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Slovakia. 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 28 Sep 2016). 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?

Progression-free Survival (time frame: From randomization to progression or death during the study (up to approximately 30 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 NCT01399190.

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 28 Sep 2016.