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Treatment Patterns in Advanced Small Cell Lung Cancer (SCLC)

11 januari 2022 uppdaterad av: Bristol-Myers Squibb

Treatment Patterns Among Patients With Advanced Small Cell Lung Cancer (SCLC) in Europe

Non-interventional, retrospective study of advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]) with the aim to produce evidence across different SCLC treatment lines to characterize the clinical and economic burden of the disease in Europe.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

764

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Spanien
      • Barcelona, Spanien, 08025
        • Local Institution
  • Storbritannien
      • London, Storbritannien, N19JY
        • Local Institution

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Advanced SCLC patients in 4 European countries (France, Germany, Italy, and United Kingdom [UK]).

Beskrivning

Inclusion Criteria:

Cohort 1 and 2:

  • Patients 18 years of age or older at SCLC diagnosis
  • Confirmed diagnosis of SCLC within the patient identification period (between October 2013 and October 2015)
  • Initiated on first-line treatment (radiotherapy and/or chemotherapy) for their SCLC
  • Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
  • Signed informed consent (where required as per local requirements)

Cohort 3:

  • Patients 18 years of age or older at SCLC diagnosis
  • Confirmed diagnosis of SCLC not earlier than October 2013
  • Initiated on second-line treatment due to relapse after first-line therapy not later than August 2016
  • Full oncology medical history for the mandatory variables of the study available in the participating center from day of diagnosis until the end of follow-up or death (whichever occurs first)
  • Signed informed consent (where required as per local requirements)

Exclusion Criteria:

  • Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to first treatment and no additional therapy is required or anticipated to be required during the study period.

Other Inclusion/Exclusion criteria may apply

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
LD-SCLC receiving 1st line treatment
patients with LD-SCLC receiving first-line treatment, including potential maintenance treatment
ED-SCLC receiving 1st line treatment
patients with ED-SCLC receiving first-line treatment, including potential maintenance treatment
relapsed/refractory receiving 2nd or later-line treatment
relapsed/refractory patients receiving second- or later-line treatment

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Distribution of Patient Demographic Characteristics
Tidsram: At baseline

Characteristics include:

Age/month and year of birth Gender Ethnicity Weight Height Smoking status Alcohol consumption Other relevant risk factors
At baseline
Distribution of Patient Clinical Characteristics in Relapsed/refractory patients receiving second- or later-line treatment
Tidsram: At baseline

Characteristics include:

Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
At baseline
Distribution of Patient Clinical Characteristics in patients with LD-SCLC
Tidsram: At baseline

Characteristics include:

Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
At baseline
Distribution of Patient Clinical Characteristics in patients with ED-SCLC
Tidsram: At baseline

Characteristics include:

Relevant comorbidities Laboratory parameters Date of initial diagnosis Staging using the VALG system Histology ECOG Performance status Tumor status Symptoms
At baseline
Distribution of treatment patterns in patients with ED-SCLC
Tidsram: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months
Distribution of treatment patterns in patients with LD-SCLC
Tidsram: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months
Distribution of treatment patterns in Relapsed/refractory patients receiving second- or later-line treatment
Tidsram: Approximately 44 months
Details on patients prior treatment Patterns will be summarized using descriptive statistics
Approximately 44 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Composite of SCLC-related healthcare resource utilization (HCRU)
Tidsram: Approximately 44 months
HCRU will include hospitalizations, emergency visits, outpatient visits, treatments received (including treatments prescribed to manage AEs), diagnostic tests and procedures, surgery, and ancillary services.
Approximately 44 months
Overall survival (OS)
Tidsram: Approximately 44 months
Approximately 44 months
Progression-free survival (PFS)
Tidsram: Approximately 44 months
Approximately 44 months
Objective response rate (ORR)
Tidsram: Approximately 44 months
Approximately 44 months
Mortality rate
Tidsram: Approximately 44 months
Approximately 44 months
Treatment-related adverse events (AEs) leading to discontinuation
Tidsram: Approximately 44 months
Approximately 44 months
Incidence of surgery as cancer-directed therapy
Tidsram: Approximately 44 months
To describe the use of surgery in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months
Incidence of radiation therapy as cancer-directed therapy
Tidsram: Approximately 44 months
To describe the use of radiation therapy in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months
Incidence of best supportive care (BSC)
Tidsram: Approximately 44 months
To describe the use of best supportive care (BSC) in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months
Incidence of palliative care
Tidsram: Approximately 44 months
To describe the use of palliative care in the management of LD-SCLC and ED-SCLC patients having relapsed
Approximately 44 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 december 2016

Primärt slutförande (Faktisk)

24 januari 2019

Avslutad studie (Faktisk)

24 januari 2019

Studieregistreringsdatum

Först inskickad

13 oktober 2017

Först inskickad som uppfyllde QC-kriterierna

1 februari 2018

Första postat (Faktisk)

8 februari 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 januari 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 januari 2022

Senast verifierad

1 januari 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CA209-913

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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