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

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ClinicalTrials.gov Identifier: NCT03836469
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Latin American Cooperative Oncology Group

Brief Summary:
• To describe patients outcomes in terms of overall survival (OS) in locally advanced NSCLC in Brazil

Condition or disease
Lung Cancer, Non-small Cell

Detailed Description:
  • To describe the demographic, clinical and pathological characteristics of patients diagnosed with locally advanced NSCLC;
  • To describe the type of definitive therapy for locally advanced NSCLC
  • To determine progression-free survival (PFS) after definitive therapy
  • To estimate time to next treatment (TNT) after definitive therapy NSCLC in Brazil;
  • To describe the patterns of recurrence/progression and treatment sequencing;
  • To test the association of demographic, clinical and pathological characteristics with PFS, OS
  • To compare the patterns of care (number of hospitalizations; visits to emergency room or ICU; outpatient unit visits) and outcomes between the private and public health care system;

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil
Estimated Study Start Date : March 4, 2019
Estimated Primary Completion Date : March 3, 2020
Estimated Study Completion Date : March 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer




Primary Outcome Measures :
  1. Overall survival [ Time Frame: Up to June 30, 2018 ]
    defined as time from diagnosis to death of any cause;


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to June 30, 2018 ]
    defined as time from any line of treatment to progression of the disease or death of any cause

  2. Time to next treatment [ Time Frame: Up to June 30, 2018 ]
    defined as time from start of the any treatment to the beginning of a second therapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient diagnosed with stage IIIA or IIIB NSCLC in the period of January 2015 to December 2016.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836469


Contacts
Contact: Laura Voelcker +55 51 3384 5334 laura.voelcker@lacog.org.br

Sponsors and Collaborators
Latin American Cooperative Oncology Group
AstraZeneca
Investigators
Study Director: Gustavo Werutsky, MD Latin American Cooperative Oncology Group

Publications:
2. Instituto Nacional de Câncer José Alencar Gomes. Estimativa 2018: Incidência de Câncer no Brasil [Internet]. Rio de Janeiro: INCA; 2018. 122 p. Available from: http://www.inca.gov.br/estimativa/2018
3. Howlader N, Noone AM, Krapcho M, Miller D, Bishop K, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA. SEER Cancer Statistics Review, 1975-2014, National Cancer Institute [Internet]. Bethesda, MD; 2016. Available from: https://seer.cancer.gov/csr/1975_2014/
5. Eldsamira Mascarenhas, Gildete Lessa. Perfil clínico e sócio-demográfico de pacientes com câncer de pulmão não-pequenas células atendidos num serviço privado. Revista Brasileira de Oncologia Clinica. 2010 Oct;7(22):49-54.
6. Debiasi M, Fay A, Viola LS, Sostruznik MH. Perfil epidemiológico e análise de sobrevida de pacientes com câncer de pulmão a partir da primeira consulta em um centro terciário de oncologia/SUS. Revista Brasileira de Oncologia Clínica. 2010;7:86-91.
14. De Lima VC, Baldotto C, Barrios C, Sobrinho E, Zukin M, Mathias C, et al. P2.02-030 Consolidation Chemotherapy Following Concurrent Chemoradiation for Stage III Non-Small Cell Lung Cancer: A Brazilian Multicentric Cohort. Journal of Thoracic Oncology. 2017 Jan;12(1):S865-6.

Responsible Party: Latin American Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT03836469     History of Changes
Other Study ID Numbers: LACOG 0118
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Latin American Cooperative Oncology Group:
Lung cancer
Non-small cell

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms