Colorectal Cancer
Conditions
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).
Interventions
OTHERBevacizumab
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_PRODUCTChemotherapy
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.
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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 | — |
| Percentage of Participants with Reason for Bevacizumab Plus Chemotherapy Treatment Discontinuation | From enrollment to the treatment discontinuation (maximum up to 36 months) | — |
Countries
Hungary
Outcome results
None listed