Tokyo, July 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058639) titled 'A prospective observational study of image-guided proton therapy for early-stage lung cancer' on July 31.
Study Type:
Observational
Primary Sponsor:
Institute - Nagoya City University West Medical Center
Condition:
Condition - early-stage lung cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To develop future treatments for early-stage lung cancer, we will conduct data registration and clinical practice (covered by insurance) as a prospective observational study in general practice, and conduct detailed analysis using our own institution's medical information.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 20
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients with non-small cell lung cancer diagnosed by histology or cytology, or those with a clinical diagnosis of lung cancer
2. Patients with clinical stage IA-II diagnosed by chest and abdominal CT, head MRI, or FDG-PET within 56 days (TNM classification: 2024, UICC 9th edition).
3. Males and females aged 20 years or older at the time of obtaining consent for treatment.
4. Patients who are able to maintain a stable position during irradiation.
5. Patients who are judged to be able to plan a treatment that does not exceed the dose limits for adjacent organs.
6. Patients who are deemed suitable for proton therapy by the Cancer Board.
7. Patients who have received an explanation of the treatment using a consent form and have given written consent for treatment.
Key exclusion criteria - 1. Pregnant or potentially pregnant patients
2. Patients whose wishes cannot be confirmed
3. Patients with active, refractory infections
4. Patients with psychiatric disorders or symptoms that make participation in this treatment protocol difficult
5. Patients with other serious complications (such as poorly controlled hypertension or diabetes, active gastrointestinal bleeding, etc.)
6. Patients who are deemed ineligible for this study by the researchers for medical, psychological, or other reasons other than those listed above.
Target Size - 200
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 07 Month 02 Day
Date of IRB - 2025 Year 07 Month 14 Day
Anticipated trial start date - 2025 Year 07 Month 18 Day
Last follow-up date - 2035 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067060
Disclaimer: Curated by HT Syndication.