An Observational Study of Continued Bevacizumab Plus Chemotherapy Until First Progression in Participants With Metastatic Colorectal Cancer (CRC)
- Conditions
- Colorectal Cancer
- Interventions
- Other: BevacizumabCombination Product: Chemotherapy
- Registration Number
- NCT02305615
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with CRC Chemotherapy 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. Participants with CRC Bevacizumab 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Baseline 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.
Percentage of Participants with Adverse Events (AEs) and Serious AEs From Baseline up to 36 months
Trial Locations
- Locations (22)
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
🇭🇺Debrecen, Hungary
Szent Margit Hospital
🇭🇺Budapest, Hungary
Semmelweis Egyetem Onkologiai Központ
🇭🇺Budapest, Hungary
Szent Imre Hospital
🇭🇺Budapest, Hungary
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly
🇭🇺Budapest, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
🇭🇺Budapest, Hungary
Josa Andras Korhaz; Dept of Oncoradiology
🇭🇺Nyíregyháza, Hungary
Szent Gyorgy Korhaz;Fejer Megyei
🇭🇺Szekesfehervar, Hungary
Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
🇭🇺Kecskemet, Hungary
Fövárosi Önkormányzat uzsoki utcai Kórház
🇭🇺Budapest, Hungary
Petz Aladar Megyei Oktato Korhaz
🇭🇺Gyor, Hungary
Pécsi Tudományegyetem Áok; Onkoterapias Intezet
🇭🇺Pecs, Hungary
Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
🇭🇺Szeged, Hungary
Tolna Megyei Onkormanyzat Balassa Janos Korhaz
🇭🇺Szekszard, Hungary
Markusovszky Hospital
🇭🇺Szombathely, Hungary
Zala megyei Önkormányzat Kórház és Rendelõintézet
🇭🇺Zalaegerszeg, Hungary
Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
🇭🇺Gyula, Hungary
Kaposi Mor Teaching Hospital
🇭🇺Kaposvár, Hungary
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
🇭🇺Miskolc, Hungary
Kenezy Korhaz Rendelointezet
🇭🇺Debrecen, Hungary
Szent Borbala Korhaz
🇭🇺Tatabánya, Hungary
Veszprem Megyei Csolnoky; Ferenc Korhaz
🇭🇺Veszprem, Hungary