About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Postoperative hypo-fractionated radiotherapy