Real world data analysis of treatment pattern and prognosis of patients with Limited-Stage Small Cell Lung Cancer (LS-SCLC) in Japan

JRCT ID: jRCT1030230655

Registered date:27/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Limited-Stage Small Cell Lung Cancer
• Date of first enrollment: 27/02/2024
• Target sample size: 500
• Study type: Observational

Outcome(s)

• Primary Outcome: 1. Median OS with each 95 percent confidence interval (CI) from the start of 1L treatment in FAS and in each 1L treatment cohort

Secondary Outcome

1. Median rwPFS with each 95 percent CI from the start of 1L treatment in FAS and in each 1L treatment cohort
2. Proportion of each treatment pattern (cCRT, sCRT, CT alone) in each 1L treatment cohort
3. Median rwPFS and OS with each 95% CI from the start of each 1L treatment for aged subgroup in each 1L treatment cohort
4. Proportion of recurrence pattern after 1L therapy (Local recurrence, distant metastasis without brain metastasis, or distant metastasis with brain metastasis) in each 1L treatment cohort
5. Proportion of rwTR (CR/PR/SD/PD/NE) in each 1L treatment cohort
6. Proportion of incidence of AEs associated with cCRT and sCRT in cCRT and sCRT cohort

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients with LS-SCLC pathologically diagnosed by tissue or cytology between January 2014 and December 2020
2. Patients provided written informed consent, in cases where obtaining informed consent is not difficult, or appropriate opt out approach was taken for this study
3. Patient aged 18 years or older at the time of diagnosis of LS-SCLC
4. Patient with access to accurate data from medical records by PIs judgment

Exclude criteria

1. Patients participating in clinical trials during the observation period of the study
2. Patients who received surgery or only radiation therapy (including SBRT) as 1L treatment for LS-SCLC, and who received no treatment or only best supportive care (BSC) without active treatment for LS-SCLC

Related Information

• Primary Sponsor: Kitagawa Hiroshi
• Source(s) of Monetary Support: AstraZeneca K.K.