An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
AVACONT
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
1 other identifier
observational
300
1 country
22
Brief 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 bevacizumab Summary of Product Characteristics (SmPC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2015
Typical duration for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2014
CompletedFirst Posted
Study publicly available on registry
December 2, 2014
CompletedStudy Start
First participant enrolled
January 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2017
CompletedAugust 23, 2018
August 1, 2018
3 years
November 28, 2014
August 22, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
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
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
From enrollment up to death from any cause, maximum up to 1 year
Duration of Bevacizumab Plus Chemotherapy Treatment
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)
From Baseline up to 36 months
Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation
From enrollment to the treatment discontinuation (maximum up to 36 months)
- +2 more secondary outcomes
Study Arms (1)
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.
Interventions
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.
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.
Eligibility Criteria
Adult participants with metastatic CRC in first-line setting in Hungary
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Szent Margit Hospital
Budapest, 1032, Hungary
Semmelweis Egyetem Onkologiai Központ
Budapest, 1083, Hungary
Szent Imre Hospital
Budapest, 1115, Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, 1122, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, 1125, Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
Budapest, 1145, Hungary
Kenezy Korhaz Rendelointezet
Debrecen, 4031, Hungary
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
Debrecen, 4032, Hungary
Petz Aladar Megyei Oktato Korhaz
Győr, 9024, Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
Gyula, 5703, Hungary
Kaposi Mor Teaching Hospital
Kaposvár, 7400, Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
Kecskemét, 6000, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
Miskolc, 3501, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
Nyíregyháza, 4400, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
Pécs, 7624, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
Szeged, 6720, Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Szent Gyorgy Korhaz;Fejer Megyei
Székesfehérvár, 8000, Hungary
Markusovszky Hospital
Szombathely, 9700, Hungary
Szent Borbala Korhaz
Tatabánya, 2800, Hungary
Veszprem Megyei Csolnoky; Ferenc Korhaz
Veszprém, 8200, Hungary
Zala megyei Önkormányzat Kórház és Rendelõintézet
Zalaegerszeg, 8900, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2014
First Posted
December 2, 2014
Study Start
January 13, 2015
Primary Completion
December 29, 2017
Study Completion
December 29, 2017
Last Updated
August 23, 2018
Record last verified: 2018-08