<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03836469</url>
  </required_header>
  <id_info>
    <org_study_id>LACOG 0118</org_study_id>
    <nct_id>NCT03836469</nct_id>
  </id_info>
  <brief_title>Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil</brief_title>
  <acronym>RELANCE</acronym>
  <official_title>Retrospective Epidemiological Study of Locally Advanced Non Small Cell Lung Cancer Patients in Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Latin American Cooperative Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Latin American Cooperative Oncology Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      • To describe patients outcomes in terms of overall survival (OS) in locally advanced NSCLC&#xD;
      in Brazil&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  To describe the demographic, clinical and pathological characteristics of patients&#xD;
           diagnosed with locally advanced NSCLC;&#xD;
&#xD;
        -  To describe the type of definitive therapy for locally advanced NSCLC&#xD;
&#xD;
        -  To determine progression-free survival (PFS) after definitive therapy&#xD;
&#xD;
        -  To estimate time to next treatment (TNT) after definitive therapy NSCLC in Brazil;&#xD;
&#xD;
        -  To describe the patterns of recurrence/progression and treatment sequencing;&#xD;
&#xD;
        -  To test the association of demographic, clinical and pathological characteristics with&#xD;
           PFS, OS&#xD;
&#xD;
        -  To compare the patterns of care (number of hospitalizations; visits to emergency room or&#xD;
           ICU; outpatient unit visits) and outcomes between the private and public health care&#xD;
           system;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2019</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to June 30, 2018</time_frame>
    <description>defined as time from diagnosis to death of any cause;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Up to June 30, 2018</time_frame>
    <description>defined as time from any line of treatment to progression of the disease or death of any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next treatment</measure>
    <time_frame>Up to June 30, 2018</time_frame>
    <description>defined as time from start of the any treatment to the beginning of a second therapy</description>
  </secondary_outcome>
  <enrollment type="Actual">403</enrollment>
  <condition>Lung Cancer, Non-small Cell</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient diagnosed with stage IIIA or IIIB NSCLC in the period of January 2015 to December&#xD;
        2016.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 18 years or older&#xD;
&#xD;
          2. Histologically or cytological diagnosis of NSCLC in the period of January 2015 to&#xD;
             December 2016&#xD;
&#xD;
          3. Locally Advanced NSCLC defined as clinical stage IIIA and IIIB according to 7th&#xD;
             Edition TNM Staging System&#xD;
&#xD;
          4. Any NSCLC histological subtype and molecular mutation&#xD;
&#xD;
          5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis&#xD;
&#xD;
          6. Patients assigned by treating physician to any therapy or palliative care&#xD;
&#xD;
          7. Access to patient medical chart for data collection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Small cell lung cancer and non-invasive NSCLC;&#xD;
&#xD;
          2. Synchronic NSCLC or second primary tumour in the last 5 years (except non-melanoma&#xD;
             skin cancer).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gustavo Werutsky, MD</last_name>
    <role>Study Director</role>
    <affiliation>Latin American Cooperative Oncology Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NOB</name>
      <address>
        <city>Salvador</city>
        <state>BA</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IMIP</name>
      <address>
        <city>Recife</city>
        <state>PE</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Caridade de Carazinho</name>
      <address>
        <city>Carazinho</city>
        <state>Rio Grande Do Sul</state>
        <zip>99500-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COI</name>
      <address>
        <city>Rio De Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INCA</name>
      <address>
        <city>Rio De Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto D'OR</name>
      <address>
        <city>Rio De Janeiro</city>
        <state>RJ</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CPO Pucrs</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica de Oncologia Reichow</name>
      <address>
        <city>Blumenau</city>
        <state>Santa Catarina</state>
        <zip>89010-340</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AC Camargo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beneficência Portuguesa</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICESP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.</citation>
    <PMID>25220842</PMID>
  </reference>
  <reference>
    <citation>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</citation>
  </reference>
  <reference>
    <citation>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/</citation>
  </reference>
  <reference>
    <citation>Younes RN, Deutsch F, Badra C, Gross J, Haddad F, Deheinzelin D. Nonsmall cell lung cancer: evaluation of 737 consecutive patients in a single institution. Rev Hosp Clin Fac Med Sao Paulo. 2004 Jun;59(3):119-27. doi: 10.1590/s0041-87812004000300005. Epub 2004 Jul 28.</citation>
    <PMID>15286831</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Ramnath N, Dilling TJ, Harris LJ, Kim AW, Michaud GC, Balekian AA, Diekemper R, Detterbeck FC, Arenberg DA. Treatment of stage III non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e314S-e340S. doi: 10.1378/chest.12-2360.</citation>
    <PMID>23649445</PMID>
  </reference>
  <reference>
    <citation>Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.</citation>
    <PMID>20351327</PMID>
  </reference>
  <reference>
    <citation>van Meerbeeck JP, Kramer GW, Van Schil PE, Legrand C, Smit EF, Schramel F, Tjan-Heijnen VC, Biesma B, Debruyne C, van Zandwijk N, Splinter TA, Giaccone G; European Organisation for Research and Treatment of Cancer-Lung Cancer Group. Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer. J Natl Cancer Inst. 2007 Mar 21;99(6):442-50. doi: 10.1093/jnci/djk093.</citation>
    <PMID>17374834</PMID>
  </reference>
  <reference>
    <citation>Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, Hasegawa Y, Ou SH, Takada M, Ando M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol. 2013 Sep;8(9):1181-9. doi: 10.1097/JTO.0b013e3182988348.</citation>
    <PMID>23883782</PMID>
  </reference>
  <reference>
    <citation>Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.</citation>
    <PMID>28885881</PMID>
  </reference>
  <reference>
    <citation>Domingues PM, Zylberberg R, da Matta de Castro T, Baldotto CS, de Lima Araujo LH. Survival data in elderly patients with locally advanced non-small cell lung cancer. Med Oncol. 2013 Mar;30(1):449. doi: 10.1007/s12032-012-0449-8. Epub 2013 Jan 10.</citation>
    <PMID>23307257</PMID>
  </reference>
  <reference>
    <citation>de Sa VK, Coelho JC, Capelozzi VL, de Azevedo SJ. Lung cancer in Brazil: epidemiology and treatment challenges. Lung Cancer (Auckl). 2016 Nov 14;7:141-148. doi: 10.2147/LCTT.S93604. eCollection 2016.</citation>
    <PMID>28210170</PMID>
  </reference>
  <reference>
    <citation>Cordeiro de Lima VC, Baldotto CS, Barrios CH, Sobrinho EM, Zukin M, Mathias C, Zaffaroni F, Nery RC, Madeira G, Amadio AV, Coelho JC, Geib G, Simoes MF, Castro G Jr. Stage III Non-Small-Cell Lung Cancer Treated With Concurrent Chemoradiation Followed or Not by Consolidation Chemotherapy: A Survival Analysis From a Brazilian Multicentric Cohort. J Glob Oncol. 2018 Sep;4:1-11. doi: 10.1200/JGO.17.00214.</citation>
    <PMID>30241276</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>January 5, 2023</last_update_submitted>
  <last_update_submitted_qc>January 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer</keyword>
  <keyword>Non-small cell</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03836469
org study id: LACOG 0118
nct id: NCT03836469
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
• To describe patients outcomes in terms of overall survival (OS) in locally advanced NSCLC
      in Brazil
-  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;
observational model: Cohort
time perspective: Retrospective
measure: Overall survival
time frame: Up to June 30, 2018
description: defined as time from diagnosis to death of any cause;
measure: Progression free survival
time frame: Up to June 30, 2018
description: defined as time from any line of treatment to progression of the disease or death of any cause
measure: Time to next treatment
time frame: Up to June 30, 2018
description: defined as time from start of the any treatment to the beginning of a second therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Gustavo Werutsky, MD
role: Study Director
affiliation: Latin American Cooperative Oncology Group
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
citation: Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PMID: 25220842
citation: 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
citation: 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/
citation: Younes RN, Deutsch F, Badra C, Gross J, Haddad F, Deheinzelin D. Nonsmall cell lung cancer: evaluation of 737 consecutive patients in a single institution. Rev Hosp Clin Fac Med Sao Paulo. 2004 Jun;59(3):119-27. doi: 10.1590/s0041-87812004000300005. Epub 2004 Jul 28.
PMID: 15286831
citation: 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.
citation: 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.
citation: Ramnath N, Dilling TJ, Harris LJ, Kim AW, Michaud GC, Balekian AA, Diekemper R, Detterbeck FC, Arenberg DA. Treatment of stage III non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e314S-e340S. doi: 10.1378/chest.12-2360.
PMID: 23649445
citation: Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
PMID: 20351327
citation: van Meerbeeck JP, Kramer GW, Van Schil PE, Legrand C, Smit EF, Schramel F, Tjan-Heijnen VC, Biesma B, Debruyne C, van Zandwijk N, Splinter TA, Giaccone G; European Organisation for Research and Treatment of Cancer-Lung Cancer Group. Randomized controlled trial of resection versus radiotherapy after induction chemotherapy in stage IIIA-N2 non-small-cell lung cancer. J Natl Cancer Inst. 2007 Mar 21;99(6):442-50. doi: 10.1093/jnci/djk093.
PMID: 17374834
citation: Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, Hasegawa Y, Ou SH, Takada M, Ando M. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literature. J Thorac Oncol. 2013 Sep;8(9):1181-9. doi: 10.1097/JTO.0b013e3182988348.
PMID: 23883782
citation: Antonia SJ, Villegas A, Daniel D, Vicente D, Murakami S, Hui R, Yokoi T, Chiappori A, Lee KH, de Wit M, Cho BC, Bourhaba M, Quantin X, Tokito T, Mekhail T, Planchard D, Kim YC, Karapetis CS, Hiret S, Ostoros G, Kubota K, Gray JE, Paz-Ares L, de Castro Carpeno J, Wadsworth C, Melillo G, Jiang H, Huang Y, Dennis PA, Ozguroglu M; PACIFIC Investigators. Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Nov 16;377(20):1919-1929. doi: 10.1056/NEJMoa1709937. Epub 2017 Sep 8.
PMID: 28885881
citation: Domingues PM, Zylberberg R, da Matta de Castro T, Baldotto CS, de Lima Araujo LH. Survival data in elderly patients with locally advanced non-small cell lung cancer. Med Oncol. 2013 Mar;30(1):449. doi: 10.1007/s12032-012-0449-8. Epub 2013 Jan 10.
PMID: 23307257
citation: de Sa VK, Coelho JC, Capelozzi VL, de Azevedo SJ. Lung cancer in Brazil: epidemiology and treatment challenges. Lung Cancer (Auckl). 2016 Nov 14;7:141-148. doi: 10.2147/LCTT.S93604. eCollection 2016.
PMID: 28210170
citation: Cordeiro de Lima VC, Baldotto CS, Barrios CH, Sobrinho EM, Zukin M, Mathias C, Zaffaroni F, Nery RC, Madeira G, Amadio AV, Coelho JC, Geib G, Simoes MF, Castro G Jr. Stage III Non-Small-Cell Lung Cancer Treated With Concurrent Chemoradiation Followed or Not by Consolidation Chemotherapy: A Survival Analysis From a Brazilian Multicentric Cohort. J Glob Oncol. 2018 Sep;4:1-11. doi: 10.1200/JGO.17.00214.
PMID: 30241276
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Undecided