Clinical Trial: A nationwide prospective observational study of high-precision hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis (Japan)

Tokyo, July 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062261) titled 'A nationwide prospective observational study of high-precision hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis' on July 21.

Study Type: Observational

Primary Sponsor: Institute - Japan Radiation Oncology Study Group

Condition: Condition - non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - We will conduct a multicenter, prospective registry of patient data on high-precision, hypofractionated radiation therapy for centrally located non-small cell lung cancer with tumor diameter less than 3cm without metastasis in Japan, in order to assess the actual treatment outcomes and adverse events. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Meet either criterion 1. or 2. below. 1. Pathologically confirmed non-small cell lung cancer 2. Meet criteria a) through d) below and have been clinically diagnosed with primary non-small cell lung cancer. a) An increase in tumor size of 1 mm or more is observed on chest CT scans performed at least twice at intervals of 28 days or more b) There is clear abnormal uptake on FDG-PET. c) NSE and Pro-GRP levels, as measured within 28 days prior to enrollment, are within the institution's reference range. d) No tumor-associated syndromes (SIADH, ectopic ACTH syndrome, Lambert-Eaton syndrome) are present. 2) Located within 2 cm of central structures (trachea, bronchi (up to the second-order branches), major blood vessels, esophagus, heart, brachial plexus, or spinal cord); eligibility is met if even a portion of the tumor is within this range (including ground-glass opacities). 3) Based on contrast-enhanced chest and abdominal CT performed within 56 days prior to enrollment, as well as FDG-PET and contrast-enhanced head MRI performed within 84 days prior to enrollment, the total diameter of the lesion must be 3 cm or less, and there must be no evidence of lymph node or distant metastases (cases diagnosed by staging using non-contrast CT or MRI when contrast-enhanced imaging is not feasible, or head CT when MRI is not feasible, are also eligible). 4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) is 0-2. 5) Age is 20 years or older. 6) High-precision irradiation (position reproducibility of the irradiation center within 5 mm for each fraction) is planned. 7) Meets the criteria for one of the three standard dose fractionation schemes and dose constraints. 8) Treatment is planned using a standard dose fractionation scheme and dose constraints that meet the criteria. Key exclusion criteria - 1) Concurrent or sequential combination drug therapy for the underlying condition is planned. 2) The patient has a severe mental illness. 3) The attending physician deems the patient unsuitable for participation in this study for other reasons. Target Size - 81

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2024 Year 12 Month 24 Day Date of IRB - 2024 Year 12 Month 24 Day Anticipated trial start date - 2025 Year 04 Month 14 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071246

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