Tokyo, Oct. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059583) titled 'Alectinib and Local Therapy for Optimal Treatment in ALK-Positive non-small cell lung cancer (ALTHEO Study)' on Oct. 30.
Study Type:
Observational
Primary Sponsor:
Institute - Specified Nonprofit Corporation North East Japan Study Group
Condition:
Condition - ALK fusion gene-positive lung cancer.
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - This study aims to elucidate the clinical significance of performing local treatment for brain metastases before systemic therapy in patients with ALK-positive lung cancer with brain metastases.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who started treatment with Alectinib for advanced or recurrent NSCLC with ALK fusion gene positivity between September 1, 2014 and December 31, 2022.
Key exclusion criteria - 1. Patients with a history of ALK-TKI administration prior to alectinib administration (patients with a history of chemotherapy other than ALK-TKI are eligible for inclusion).
2. Patients with meningeal carcinomatosis prior to alectinib administration.
3. Patients who refused to participate in this study based on the informed consent document.
4. Patients whom the principal investigator or co-investigator deemed unsuitable for participation in this study.
Target Size - 700
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 10 Month 13 Day
Date of IRB - 2025 Year 10 Month 13 Day
Anticipated trial start date - 2025 Year 10 Month 20 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068148
Disclaimer: Curated by HT Syndication.
