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Colorectal cancer is one of the most common tumors and is the second most prevalent cause of cancer death, leading to almost 1 million deaths per year.Elovie is a bevacizumab biosimilar medicine marketed by Libbs Farmacêutica, which had its registration approved by ANVISA in May 2022.At the time of registration a robust evidence package was presented that included, for example, pharmacokinetic bioequivalence studies in patients with metastatic RCC (mRCC) and a phase III study in participants with non-small cell lung cancer .Conducting a real-world study to evaluate the effectiveness and safety of bevacizumab biosimilar Elovie in patients with mCRC is crucial to provide relevant information on how this therapy behaves in real-world clinical conditions in brazilian population.
Observational, multicenter study with real-world data from specialized cancer centers in Brazil. Participants over 18 years of age, of both sexes, with unresectable clinical stage IV metastatic colorectal cancer, who have received Elovie® (bevacizumab biosimilar) at participating centers and who meet the eligibility criteria will be invited to participate. In this study, data on the effectiveness and safety of treatment with Elovie, as well as clinical and demographic characteristics and treatment patterns will be collected.
Participants will undergo standard treatment and clinical follow-up as determined by the treating physician.
Data collection will be performed by the researcher and the data transcribed into the Case Report Form data collection form designed specifically for the study.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of treatment with bevacizumab | Median duration in months and number of cycles of first-line treatment until the switch to second-line treatment, for any reason, through the collection of electronic medical record data. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | progression-free survival will be defined as the median time (in months) from the first dose of bevacizumab to disease progression | 24 months |
| Overall survival | Overall survival will be defined as the median time (in months) from the first dose of bevacizumab until the occurrence of death, from any cause, during the 24-month follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants of both sexes diagnosed with metastatic colorectal cancer, clinical stage IV unresectable, by clinical definition in medical records, according to the investigator's assessment at the initial consultation and before any type of palliative treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unimed Vitória | Recruiting | Vitória | Espírito Santo | 29047660 | Brazil |
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| 24 months |
| The survival rate | The survival rate will be defined as the number and proportion of participants who remained alive after 24 months of follow-up | 24 months |
| Objective Response Rate | The Objective Response Rate will be defined as the number and percentage of participants who had a Complete Response or Partial Response, using the usual methodology of the research center, during 24 months of follow-up after the start of bevacizumab use. The number and percentage of participants who had Stable Disease or Disease Progression will also be evaluated. | 24 months |
| Functional capacity | Functional capacity will be assessed using the ECOG (Eastern cooperative oncology group) scale during 24 months of follow-up after starting bevacizumab. Scale ECOG Grade 0 - Fully active, able to carry on all pre disease performance without restriction Grade 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Grade 5 - Dead https://ecog-acrin.org/resources/ecog-performance-status/ | 24 months |
| Safety assessment | To assess the occurrence of adverse events in the 24-month follow-up period since the first dose of Elovie.Assess the median duration of treatment through time in months and number of cycles until switching to another treatment other than the first line, for reasons of toxicity (adverse event). | 24 months |
| Centro de Oncologia do Paraná (COP) | Recruiting | Curitiba | Paraná | 82305-100 | Brazil |
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| Centro de Pesquisa Unimed Londrina | Recruiting | Londrina | Paraná | 86050-460 | Brazil |
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| Instituto Dor de Pesquisa E Ensino | Recruiting | Recife | Pernambuco | 50070-480 | Brazil |
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| Centro de Ensino e Pesquisa - Hospital São Marcos | Recruiting | Teresina | Piauí | 64002-595 | Brazil |
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| Centro de Pesquisa Unimed Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90560-003 | Brazil |
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| Associação Hospitalar Moinhos de Vento | Recruiting | Porto Alegre | Rio Grande do Sul | 90560-032 | Brazil |
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| Unidade de Ensino e Pesquisa UEP-COHM | Recruiting | Santo Ângelo | Rio Grande do Sul | 98.801.706 | Brazil |
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| OncoJaraguá | Recruiting | Jaraguá do Sul | Santa Catarina | 89253-080 | Brazil |
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| Hospital Vera Cruz | Recruiting | Campinas | São Paulo | 13092-108 | Brazil |
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| CEON+ Pesquisas | Recruiting | São Caetano do Sul | São Paulo | 09541-270 | Brazil |
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| COE Ensino e Pesquisa | Recruiting | São José dos Campos | São Paulo | 12243-580 | Brazil |
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| Centro Paulista de Oncologia | Recruiting | São Paulo | São Paulo | 04.538-135 | Brazil |
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| Instituto Dor de Pesquisa E Ensino | Recruiting | São Paulo | São Paulo | Brazil |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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