This is a prospective, open-label, single-arm Phase II study designed to evaluate the safety of postoperative hypofractionated radiotherapy in patients with Stage II/III thymic epithelial tumors after complete resection. After a screening period of up to 28 days, eligible patients will receive adjuvant hypofractionated radiotherapy to a total dose of 40 Gy in 15 fractions, delivered once daily at 2.67 Gy per fraction, 5 days per week over 3 weeks. The study will primarily assess treatment-related safety and tolerability, with preliminary evaluation of efficacy, economic burden, and quality of life.
Patients who voluntarily agree to participate in this study, sign the informed consent form, demonstrate good compliance, and are willing to comply with scheduled follow-up visits.
Age 18-75 years, male or female.
Histopathologically confirmed thymoma or thymic carcinoma after R0 complete resection. Eligible disease stages according to the Masaoka-Koga staging system include Stage II-III thymic carcinoma, Stage IIA Type B3 thymoma, Stage IIB Type B2/B3 thymoma, and Stage III thymoma.
Eastern Cooperative Oncology Group performance status of 0-1.
Patients who do not meet the protocol-specified requirements for pathological type, disease stage, or histological subtype.
Patients who have not undergone surgical treatment, or who underwent R1 or R2 resection, or who have definite gross residual disease.
Prior thoracic radiotherapy.
Major surgery other than the tumor resection procedure or severe trauma within 4 weeks before the first radiotherapy treatment.
Single group
Postoperative hypo-fractionated radiotherapy
RadiationThe investigational treatment consists of postoperative hypofractionated radiotherapy delivered at a total dose of 40 Gy in 15 fractions (2.67 Gy per fraction), administered 5 days per week.
Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
Percentage of participants who experience treatment-related Grade 2 or higher acute adverse events from the start of radiotherapy to 3 months after completion of radiotherapy, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
Disease-Free Survival
Time from the start of radiotherapy to the first documented disease recurrence, distant metastasis, or death from any cause, whichever occurs first.
Overall Survival
Time from the start of radiotherapy to death from any cause.
Locoregional Recurrence Rate
ercentage of participants who develop locoregional recurrence during follow-up. Locoregional recurrence includes recurrence in the tumor bed, mediastinum, pleura, or regional lymph nodes, as assessed by imaging, pathology, or clinical evaluation.
Distant Metastasis Rate
Percentage of participants who develop distant metastasis during follow-up, as assessed by imaging, pathology, or clinical evaluation.
Odds Ratios for Cardiac-Related Disease Occurrence According to Predefined Cardiac and Coronary Artery Dose Parameters
Odds ratios for cardiac-related disease occurrence per 1-Gy increase in predefined cardiac and coronary artery dose parameters will be estimated using logistic regression. Predefined dose parameters will include mean heart dose and coronary artery substructure dose parameters, measured in Gray (Gy) from the radiotherapy treatment plan. Cardiac-related disease occurrence will be defined as the occurrence of clinically diagnosed cardiac disease or cardiac adverse events during follow-up, assessed by clinical cardiac evaluation and NCI-CTCAE v5.0. Cardiac-related diseases or adverse events may include coronary artery disease, myocardial ischemia or infarction, arrhythmia, heart failure, pericardial disease, or other clinically diagnosed cardiac events.
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