Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil

Lung Cancer, Non-small Cell Clinical Trial

— RELANCE  

Official title:

Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03836469
• Other study ID #: LACOG 0118
• Status: Completed
• Start date: September 25, 2019
• Est. completion date: June 9, 2022

Study information

• Verified date: February 2024
• Source: Latin American Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RELANCE is a large multi-institutional study that aims to retrospectively collect information about diagnostic, treatment and outcome of patients diagnosed with locally advanced NSCLC in Brazil. It is hypothesized that there is a great heterogeneity in treatment patterns owing to inequities in access to adequate staging methods, optimal treatment and multidisciplinary teams in Brazil.

Description:

RELANCE study will collect sociodemographic and clinical data of patients diagnosed with locally advanced NSCLC in the period of January 2015 and Jun 2019 in the participating institutions. Socio-demographic characteristics, clinicopathological features, treatments patterns and outcomes will be recovered from medical charts. Disease status and survival data will be collected up to the last date of follow-up June 2021.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 18 years or older;

2. Histologically or cytological diagnosis of NSCLC in the period of January 2015 to December 2016;

3. Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th Edition TNM Staging System;

4. Any NSCLC histological subtype and molecular mutation;

5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;

6. Patients assigned by treating physician to any therapy or palliative care;

7. Access to patient medical chart for data collection.

Exclusion Criteria:

1. Small cell lung cancer and non-invasive NSCLC;

2. Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma skin cancer).

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Non-small Cell
• Lung Neoplasms

Locations

Country	Name	City	State
Brazil	AC Camargo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Latin American Cooperative Oncology Group	AstraZeneca

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	defined as time from diagnosis to death of any cause;	Up to June 30, 2018
Secondary	Progression free survival	defined as time from any line of treatment to progression of the disease or death of any cause	Up to June 30, 2018
Secondary	Time to next treatment	defined as time from start of the any treatment to the beginning of a second therapy	Up to June 30, 2018