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

Colorectal Cancer Clinical Trial

— AVACONT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02305615
• Other study ID #: ML29425
• Status: Completed
• Start date: January 13, 2015
• Est. completion date: December 29, 2017

Study information

• Verified date: August 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 bevacizumab Summary of Product Characteristics (SmPC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 29, 2017
• Est. primary completion date: December 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.

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.

Locations

Country	Name	City	State
Hungary	Fövárosi Önkormányzat uzsoki utcai Kórház	Budapest
Hungary	Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly	Budapest
Hungary	Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika	Budapest
Hungary	Semmelweis Egyetem Onkologiai Központ	Budapest
Hungary	Szent Imre Hospital	Budapest
Hungary	Szent Margit Hospital	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont ; Department of Oncology	Debrecen
Hungary	Kenezy Korhaz Rendelointezet	Debrecen
Hungary	Petz Aladar Megyei Oktato Korhaz	Gyor
Hungary	Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek	Gyula
Hungary	Kaposi Mor Teaching Hospital	Kaposvár
Hungary	Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont	Kecskemet
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly	Miskolc
Hungary	Josa Andras Korhaz; Dept of Oncoradiology	Nyíregyháza
Hungary	Pécsi Tudományegyetem Áok; Onkoterapias Intezet	Pecs
Hungary	Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika	Szeged
Hungary	Szent Gyorgy Korhaz;Fejer Megyei	Szekesfehervar
Hungary	Tolna Megyei Onkormanyzat Balassa Janos Korhaz	Szekszard
Hungary	Markusovszky Hospital	Szombathely
Hungary	Szent Borbala Korhaz	Tatabánya
Hungary	Veszprem Megyei Csolnoky; Ferenc Korhaz	Veszprem
Hungary	Zala megyei Önkormányzat Kórház és Rendelõintézet	Zalaegerszeg

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Percentage of Participants who were Alive at 1 Year		From enrollment up to death from any cause, maximum up to 1 year
Secondary	Duration of Bevacizumab Plus Chemotherapy Treatment		From Baseline up to 36 months
Secondary	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
Secondary	Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation		From enrollment to the treatment discontinuation (maximum up to 36 months)
Secondary	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 [	Baseline
Secondary	Percentage of Participants with Adverse Events (AEs) and Serious AEs		From Baseline up to 36 months