Neuroendocrine Carcinomas: Patient Journey And Treatment Outcomes In Latin America
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLatin American Cooperative Oncology Group
About this trial
This observational, retrospective study aims to understand the treatment patterns and outcomes of patients with pulmonary and extra-pulmonary neuroendocrine carcinomas (NEC) in Latin America (Brazil, Mexico, Argentina, and Peru). The research will collect data from medical records to analyze factors like patient demographics, diagnosis methods, tumor characteristics, treatment approaches, and disease progression. The study is non-interventional, meaning patient care will follow standard clinical practice, with data gathered via an electronic system.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Extrapulmonary Neuroendocrine Carcinoma (EP-NEC)
Large-cell neuroendocrine carcinoma (LCNEC) or mixed
Small Cell Lung Cancer (SCLC) or mixed
Disqualifiers
Patients with active, concurrent malignancies at the time of NEC diagnosis, except for non-invasive cancers like basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer.
Patients or their legal representatives unwilling or unable to provide informed consent (if needed per ethics committee).
Trial population
Patients with extra-pulmonary neuroendocrine carcinoma (EP-NEC) and patients with pulmonary neuroendocrine carcinoma (SCLC or LCNEC) from Brazil, Mexico, Argentina and Peru.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Observational study
Other interventionThis is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Patients with extra-pulmonary neuroendocrine carcinoma1 intervention
Group B: Patients with pulmonary neuroendocrine carcinoma1 intervention
Trial outcomes
Primary outcomes
1
Patterns of Initial Cancer Treatment: number of participants treated within vs. outside high-volume sites and associated treatment characteristics
Treatment patterns will be analyzed descriptively using tables and graphs to illustrate the distribution of patients receiving initial cancer treatment within versus outside high-volume treatment centers. Key characteristics of the initial treatment will be assessed.
Time frame
Throughout the study period, an average of 24 months2
Event-free survival (EFS)
defined as time from diagnosis until relapse, death, or definitive failure of treatment strategy that implicates failure of curative-intent treatment \[for patients treated with curative intent\]. Participants who are lost to follow up or reach the study end will be censored at their last date of contact.
Time frame
Throughout the study period, an average of 24 months3
Time to treatment failure (TTF)
in first and second-line: defined as time from first dose of treatments until date of discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death. Participants who are lost to follow up or reach the study end will be censored at their last date of contact
Time frame
Throughout the study period, an average of 24 months4
Progression-free survival (PFS)
defined as time from treatment initiation until progression or death \[for patients treated with palliative intent\]. Participants who are lost to follow up or reach the study end will be censored at their last date of contact.
Time frame
Throughout the study period, an average of 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Latin American Cooperative Oncology Group
Lead sponsor
Boehringer Ingelheim
Collaborator
Grupo Argentino de Investigación Clínica en Oncología
Collaborator
Grupo de Estudios Clínicos Oncológicos Peruano
Collaborator
Source ClinicalTrials.gov