Tokyo, April 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061387) titled 'A prospective interventional study evaluating changes in pulmonary function following carbon-ion radiotherapy for lung tumors' on April 27.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - National Institutes for Quantum Science and Technology QST hospital

Condition: Condition - Patients receiving carbon-ion radiotherapy for primary lung cancer or metastatic lung tumors Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate pulmonary function in patients with primary lung cancer or metastatic lung tumors treated with carbon-ion radiotherapy, and to analyze the impact of the treatment on respiratory function and its association with follow-up data, including post-treatment adverse events. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Pulmonary function tests at approximately 3, 6, and 12 months after carbon-ion radiotherapy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients scheduled to undergo carbon-ion radiotherapy for primary lung cancer or metastatic lung tumors between the date of institutional approval and December 31, 2029, OR patients who have provided consent for the existing study at our institution (N25-013: A prospective observational study evaluating changes in pulmonary function following carbon-ion radiotherapy for lung tumors), provided they are capable of giving written informed consent for this study.

2. Patients aged 18 years or older at the time of informed consent (regardless of gender).

3. Patients who are scheduled to visit our institution for follow-up for at least 1 year after the completion of treatment.

4. Patients judged by an investigator or attending physician to be capable of understanding the informed consent document. Key exclusion criteria - Patients judged by an investigator or attending physician to be ineligible for this study Target Size - 250

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 18 Day Date of IRB - 2026 Year 04 Month 27 Day Anticipated trial start date - 2026 Year 05 Month 04 Day Last follow-up date - 2030 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070237

Disclaimer: Curated by HT Syndication.