Metastatic Colorectal CancerCONCERTNCT02612077

Observation of Patients With Metastatic Colorectal Cancer Starting Chemotherapy Combined With Bevacizumab (Avastin)

An observational study of Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 1 site in France.

Completed

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

Trial summary

This is a longitudinal, multicenter, prospective, pharmacoepidemiological study to evaluate progression free survival (PFS) in a real-life setting in participants with metastatic colorectal cancer (mCRC) starting chemotherapy combined with bevacizumab. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Colorectal Cancer
What is being tested?: Observational Chemotherapy and Concomitant Bevacizumab
How many people: 765 participants
Where: 1 siteFrance
Study dates: May 2008to Oct 2012
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 (mCRC) starting chemotherapy combined with bevacizumab.

Who may be able to join

Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy
Having received oral and written information about the survey and not objecting to having his/her data computerized

Who cannot join

Participating in a clinical trial assessing an anticancer treatment

Trial locations and contacts

1 site in 1 country.

France1 site

Study site
Neuilly-sur-Seine, 92521

Other trials in France

About this study

Official title: A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®

Conditions: Metastatic Colorectal Cancer
Being tested: Observational Chemotherapy, Concomitant Bevacizumab
Medical subject headings: Colorectal Neoplasms

What participants receive

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

Observational ChemotherapyOther
No intervention - Observational standard practice chemotherapy
Concomitant BevacizumabDrug
Also called Avastin
No intervention - Observational concomitant bevacizumab

Study groups in NCT02612077
Study group	Role	What they receive
Observational Chemotherapy/Bevacizumab		Observed patients receiving chemotherapy with concomitant bevacizumab Receives: Other: Observational Chemotherapy; Drug: Concomitant Bevacizumab

What is being measured

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

Progression-free Survival
Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively
Measured: within 36 months

Secondary outcomes (2)

Overall Survival
Overall Survival (OS) was defined as the time between the treatment start (date of the first infusion of bevacizumab) and death from any cause. Kaplan Meier estimates of median overall survival were calculated for the metastatic lines of treatment, with a median follow-up of 18, 15 and 13 months, respectively.
Measured: Up to 36 months
Quality of Life - Global Health Status
Participants rated their quality of life (global health status) on the European Organization for Research and Treatment of Cancer 30-item Core Quality of Life Questionnaire (EORTC QLQ C-30), with total scores ranging from 0 (worst) to 100 (best).
Measured: Baseline, 6 and 12 months

Timeline

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

May 2008Oct 2012

First posted23 Nov 2015 (estimated)
Study startMay 2008
Primary completionOct 2012
Study completionOct 2012

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 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: Prospective
Enrolment: 765 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02612077
Sponsor's protocol ID: ML21696
Acronym: CONCERT
Status last verified: Feb 2016
First submitted: 19 Nov 2015
Last updated: 11 Mar 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
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC

All Metastatic Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Cohort Survey of Patients With Metastatic Colorectal Cancer Starting a Chemotherapy in Combination With Avastin®
ClinicalTrials.gov ID: NCT02612077
Acronym / sponsor ID: CONCERT / ML21696
Conditions: Metastatic Colorectal Cancer
Study type: Observational
Recruitment status: Completed
Enrolment: 765 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Oct 2012 (actual)
Study completion: Oct 2012 (actual)
First posted: 23 Nov 2015 (estimated)
Results: Posted 11 Mar 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
Observational Chemotherapy/Bevacizumab	–	Other: Observational Chemotherapy, Drug: Concomitant BevacizumabObserved patients receiving chemotherapy with concomitant bevacizumab

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 (mCRC) starting chemotherapy combined with bevacizumab.

Key inclusion criteria (2 listed)

Having colon or rectal metastatic adenocarcinoma, for which the physician decided during the inclusion visit to start a treatment with bevacizumab combined with a 1st, 2nd or 3rd line chemotherapy
Having received oral and written information about the survey and not objecting to having his/her data computerized

Key exclusion criteria (1 listed)

Participating in a clinical trial assessing an anticancer treatment

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
Observational ChemotherapyNo intervention - Observational standard practice chemotherapy	Other	Observational Chemotherapy/Bevacizumab
Concomitant BevacizumabAlso: AvastinNo intervention - Observational concomitant bevacizumab	Drug	Observational Chemotherapy/Bevacizumab

Primary outcome

Progression-free Survival
Time frame: within 36 months
Kaplan Meier estimates of median progression-free survival according to the metastatic line of treatment, for a median follow-up of 18, 15 and 13 months, respectively

2 secondary outcomes

Overall Survival
Time frame: Up to 36 months
Quality of Life - Global Health Status
Time frame: Baseline, 6 and 12 months

Results and safety

Results posted to the registry on 11 Mar 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
Observational Chemotherapy/Bevacizumab	765	299

Primary outcome: Progression-free Survival

Time frame: within 36 months. Median (95% Confidence Interval). Unit: Months

Measure	Bevacizumab With 1st Line Treatment n = 521	Bevacizumab With 2nd Line Treatment n = 154	Bevacizumab With 3rd Line Treatment n = 62
Value	10.4 (9.6 to 11.3)	8.5 (7.0 to 9.2)	6.3 (4.5 to 8.9)

Population analysed: Efficacy analysis set receiving bevacizumab at inclusion

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 36 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Observational Chemotherapy/Bevacizumab	74 of 760 (9.7%)	353 of 760 (46.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Metastatic 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
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
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

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 Metastatic Colorectal Cancer, run by Hoffmann-La Roche at 1 site in France.

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 2 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 11 Mar 2016. 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 France. 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 11 Mar 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: within 36 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 NCT02612077.

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 11 Mar 2016.