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

NCT02305615

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Colorectal Cancer

Interventions: Bevacizumab, Chemotherapy

Countries: Hungary

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (22)
  • Budapest, Hungary
  • Budapest, Hungary
  • Budapest, Hungary
  • Budapest, Hungary
  • Budapest, Hungary
  • Budapest, Hungary
  • Debrecen, Hungary
  • Debrecen, Hungary
  • Győr, Hungary
  • Gyula, Hungary
  • Kaposvár, Hungary
  • Kecskemét, Hungary
  • Miskolc, Hungary
  • Nyíregyháza, Hungary
  • Pécs, Hungary
  • Szeged, Hungary
  • Szekszárd, Hungary
  • Székesfehérvár, Hungary
  • Szombathely, Hungary
  • Tatabánya, Hungary
  • Veszprém, Hungary
  • Zalaegerszeg, Hungary