Colorectal CancerAVACONTNCT02305615
An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 22 sites in Hungary.
Trial summary
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… 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 and Chemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 22 sitesHungary
- Study dates
- 13 Jan 2015to 29 Dec 2017
- 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: Adult participants with metastatic CRC in first-line setting in Hungary
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Hungary22 sites
Szent Margit Hospital
Budapest, 1032
Semmelweis Egyetem Onkologiai Központ
Budapest, 1083
Szent Imre Hospital
Budapest, 1115
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, 1125
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, 1145
Kenezy Korhaz Rendelointezet
Debrecen, 4031
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, 4032
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, 5703
Kaposi Mor Teaching Hospital
Kaposvár, 7400
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
Kecskemét, 6000
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc, 3501
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, 7624
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720
Szent Gyorgy Korhaz;Fejer Megyei
Székesfehérvár, 8000
Tolna Megyei Onkormanyzat Balassa Janos Korhaz
Szekszárd, 7100
Markusovszky Hospital
Szombathely, 9700
Szent Borbala Korhaz
Tatabánya, 2800
Veszprem Megyei Csolnoky; Ferenc Korhaz
Veszprém, 8200
Zala megyei Önkormányzat Kórház és Rendelõintézet
Zalaegerszeg, 8900
About this study
Official title: 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).
- Conditions
- Colorectal Cancer
- Being tested
- Bevacizumab, Chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabOther
Also called Avastin
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.
ChemotherapyCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Bevacizumab; Combination Product: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Measured: From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
Secondary outcomes (7)
PFS on First-Line Therapy
Measured: 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
Measured: From enrollment up to death from any cause, maximum up to 1 year
Duration of Bevacizumab Plus Chemotherapy Treatment
Measured: 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)
Measured: From Baseline up to 36 months
Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation
Measured: From enrollment to the treatment discontinuation (maximum up to 36 months)
Percentage of Participants with Protocol Defined Baseline Participant and Disease Characteristics
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.
Measured: Baseline
Percentage of Participants with Adverse Events (AEs) and Serious AEs
Measured: From Baseline up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start13 Jan 2015
- Primary completion29 Dec 2017
- Study completion29 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 300 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
- NCT02305615
- Sponsor's protocol ID
- ML29425
- Acronym
- AVACONT
- Status last verified
- Aug 2018
- First submitted
- 28 Nov 2014
- Last updated
- 23 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02305615
- Acronym / sponsor ID
- AVACONT / ML29425
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 29 Dec 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 2 Dec 2014 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with CRC | – | Other: Bevacizumab, Combination Product: ChemotherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with metastatic CRC in first-line setting in Hungary
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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: AvastinBevacizumab 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 | Participants with CRC |
| ChemotherapyFluoropyrimidine-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. | Combination product | Participants with CRC |
Primary outcome
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)
7 secondary outcomes
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)
Percentage of Participants who were Alive at 1 Year
Time frame: 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
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
Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation
Time frame: 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
Percentage of Participants with Adverse Events (AEs) and Serious AEs
Time frame: From Baseline up to 36 months
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 23 Aug 2018.
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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
22 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 22 sites in Hungary.
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 4 inclusion and 3 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 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Hungary. 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?
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)). 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 23 Aug 2018.