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

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: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Bevacizumab; Combination product: Chemotherapy

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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.	Baseline
Percentage of Participants with Adverse Events (AEs) and Serious AEs		From Baseline up to 36 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2015
• Primary Completion (Actual): December 29, 2017
• Study Completion (Actual): December 29, 2017

Study Registration Dates

• First Submitted: November 28, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 2, 2014

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: ML29425