Clinical trial NCT02305615: An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-12-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with metastatic CRC in first-line setting in Hungary

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).


Eligibility criteria: 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

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From enrollment to the first documented progression or death from any cause, whichever occurs first (maximum up to 36 months)
Secondary outcomes:
measure: PFS on First-Line Therapy
timeFrame: 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)
measure: Percentage of Participants who were Alive at 1 Year
timeFrame: From enrollment up to death from any cause, maximum up to 1 year
measure: Duration of Bevacizumab Plus Chemotherapy Treatment
timeFrame: From Baseline up to 36 months
measure: Percentage of Participants with Best Overall Response Assessed by Treating Physicians Using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: From Baseline up to 36 months
measure: Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation
timeFrame: From enrollment to the treatment discontinuation (maximum up to 36 months)
measure: Percentage of Participants with Protocol Defined Baseline Participant and Disease Characteristics
timeFrame: Baseline
measure: Percentage of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: From Baseline up to 36 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Szent Margit Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Onkologiai Központ
city: Budapest
country: Hungary
facility: Szent Imre Hospital
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Fövárosi Önkormányzat uzsoki utcai Kórház
city: Debrecen
country: Hungary
facility: Kenezy Korhaz Rendelointezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz
city: Gyula
country: Hungary
facility: Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
city: Kaposvár
country: Hungary
facility: Kaposi Mor Teaching Hospital
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
city: Miskolc
country: Hungary
facility: Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
city: Nyíregyháza
country: Hungary
facility: Josa Andras Korhaz; Dept of Oncoradiology
city: Pecs
country: Hungary
facility: Pécsi Tudományegyetem Áok; Onkoterapias Intezet
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
city: Szekesfehervar
country: Hungary
facility: Szent Gyorgy Korhaz;Fejer Megyei
city: Szekszard
country: Hungary
facility: Tolna Megyei Onkormanyzat Balassa Janos Korhaz
city: Szombathely
country: Hungary
facility: Markusovszky Hospital
city: Tatabánya
country: Hungary
facility: Szent Borbala Korhaz
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky; Ferenc Korhaz
city: Zalaegerszeg
country: Hungary
facility: Zala megyei Önkormányzat Kórház és Rendelõintézet
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: