An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC) (AVACONT)

August 22, 2018 updated by: Hoffmann-La Roche

Hungarian Multicenter Non-Interventional Study of Continued Avastin (Bevacizumab) Plus Chemotherapy Until First Progression Following Induction Treatment With Chemotherapy Doublet Plus Avastin in First Line Treatment of Patients With Metastatic Colorectal Carcinoma

This prospective, multicenter, observational study will investigate the effectiveness and safety of bevacizumab in routine clinical practice in participants with metastatic CRC. Participants are to have initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to the bevacizumab Summary of Product Characteristics (SmPC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Budapest, Hungary, 1122
        • Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
      • Budapest, Hungary, 1145
        • Fövárosi Önkormányzat uzsoki utcai Kórház
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem Onkologiai Központ
      • Budapest, Hungary, 1125
        • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
      • Budapest, Hungary, 1115
        • Szent Imre Hospital
      • Budapest, Hungary, 1032
        • Szent Margit Hospital
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
      • Debrecen, Hungary, 4031
        • Kenezy Korhaz Rendelointezet
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Oktato Korhaz
      • Gyula, Hungary, 5703
        • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
      • Kaposvár, Hungary, 7400
        • Kaposi Mor Teaching Hospital
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
      • Miskolc, Hungary, 3501
        • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
      • Nyíregyháza, Hungary, 4400
        • Josa Andras Korhaz; Dept of Oncoradiology
      • Pecs, Hungary, 7624
        • Pécsi Tudományegyetem Áok; Onkoterapias Intezet
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
      • Szekesfehervar, Hungary, 8000
        • Szent Gyorgy Korhaz;Fejer Megyei
      • Szekszard, Hungary, 7100
        • Tolna Megyei Onkormanyzat Balassa Janos Korhaz
      • Szombathely, Hungary, 9700
        • Markusovszky Hospital
      • Tatabánya, Hungary, 2800
        • Szent Borbala Korhaz
      • Veszprem, Hungary, 8200
        • Veszprem Megyei Csolnoky; Ferenc Korhaz
      • Zalaegerszeg, Hungary, 8900
        • Zala megyei Önkormányzat Kórház és Rendelõintézet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants with metastatic CRC in first-line setting in Hungary

Description

Inclusion Criteria:

  • Participants with histologically confirmed CRC with metastatic lesion
  • Participants having initiated first-line treatment with fluoropyrimidine-based doublet chemotherapy plus bevacizumab according to bevacizumab SmPC
  • Participants who previously received a minimum 9 cycles of 5-FU-based or a minimum 6 cycles of capecitabine-based induction doublet chemotherapy (i.e. 5-FU or capecitabine + oxaliplatin or irinotecan) plus bevacizumab
  • Disease evaluation showed stable disease, partial response, or complete response according to RECIST within one month

Exclusion Criteria:

  • Contraindication to receive bevacizumab according to the bevacizumab SmPC
  • Participants who received more than 10 cycles of 5-FU-based or more than 7 cycles of capecitabine-based induction doublet chemotherapy plus bevacizumab
  • Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Participants with CRC
This is an observational study; thus, no intervention or treatment is required by the protocol. During the study, the treatment will be determined according to the treating physician decision. Eligible participants will be observed for safety and efficacy of continued bevacizumab plus fluoropyrimidine-based doublet chemotherapy treatment in routine clinical practice for 1 year.
Other: Bevacizumab
Bevacizumab at a dose and schedule according to approved label and SmPC. The recommended dose of bevacizumab, administered as an intravenous infusion, is either 5 milligrams per kilogram (mg/kg) or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks. Bevacizumab is always used in combination with chemotherapy for the treatment of participants with metastatic CRC. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
Other Names:
  • Avastin
Combination product: Chemotherapy
Fluoropyrimidine-based doublet chemotherapy (5-Fluorouracil [5-FU] or capecitabine plus oxaliplatin or irinotecan) as first-line treatment; and continued fluoropyrimidine treatment with or without treatment modification for oxaliplatin or irinotecan, as per treating physician discretion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PFS on First-Line Therapy
Time Frame: From first dose of bevacizumab first-line treatment up to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
From first dose of bevacizumab first-line treatment up to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
Percentage of Participants who were Alive at 1 Year
Time Frame: From enrollment up to death from any cause, maximum up to 1 year
From enrollment up to death from any cause, maximum up to 1 year
Duration of Bevacizumab Plus Chemotherapy Treatment
Time Frame: From Baseline up to 36 months
From Baseline up to 36 months
Percentage of Participants with Best Overall Response Assessed by Treating Physicians Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: From Baseline up to 36 months
From Baseline up to 36 months
Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation
Time Frame: From enrollment to the treatment discontinuation (maximum up to 36 months)
From enrollment to the treatment discontinuation (maximum up to 36 months)
Percentage of Participants with Protocol Defined Baseline Participant and Disease Characteristics
Time Frame: Baseline
Protocol defined baseline participant and disease characteristics include: gender (male, female); age at enrollment (less than [<] 65 years, greater than or equal to [>/=] 65 years); Eastern Cooperative Oncology Group (ECOG) performance status (0,1, >/=2); primary tumor location (colon, rectum); liver metastasis only (yes, no); number and sites of organs with metastases (less than or equal to [</=] 1, greater than [>] 1); prior adjuvant chemotherapy (yes, no); resection of primary tumor (yes, no); disease stage at the time of diagnosis; disease-free interval between CRC disease diagnosis and diagnosis of metastatic stage; and mutation status (RAS, BRAF) if available.
Baseline
Percentage of Participants with Adverse Events (AEs) and Serious AEs
Time Frame: From Baseline up to 36 months
From Baseline up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 29, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML29425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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