Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060353) titled 'A multicentre observational registry study of chemoradiotherapy followed by durvalumab in limited stage small cell lung cancer' on Jan. 20.
Study Type:
Observational
Primary Sponsor:
Institute - other
Condition:
Condition - limited stage small cell lung cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate real-world PFS (rwPFS) from the start of durvalumab in LS-SCLC patients who are treated with cCRT followed by durvalumab
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1.18 years or older at time of diagnosed as LS-SCLC
2.Pathologically diagnosed as SCLC by tissue or cytology after 27th March 2025
3.Patients who have started to receive CRT (cCRT or sCRT) as 1st line treatment for SCLC
4.Provided written informed consent (for deceased patients, optout will be applicable, if accepted at the site and approved by Ethics Committee)
Key exclusion criteria - 1.Patients with any other prior treatment including surgery for SCLC
2.Patients participating in clinical trials as 1st line treatment for SCLC
3.Patients pathologically diagnosed as large cell neuroendocrine carcinoma
4.Patients with multiple cancer at the start time of 1st line treatment
5.Patients diagnosed with SCLC after tissue transformation from NSCLC
Target Size - 225
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 03 Day
Anticipated trial start date - 2026 Year 02 Month 18 Day
Last follow-up date - 2029 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068994
Disclaimer: Curated by HT Syndication.
