Status:
COMPLETED
An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
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 ha...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 13 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 29 2017
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02305615
Start Date
January 13 2015
End Date
December 29 2017
Last Update
August 23 2018
Active Locations (22)
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1
Szent Margit Hospital
Budapest, Hungary, 1032
2
Semmelweis Egyetem Onkologiai Központ
Budapest, Hungary, 1083
3
Szent Imre Hospital
Budapest, Hungary, 1115
4
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
Budapest, Hungary, 1122