Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors

Starting soon · Not applicable

Conditions studied: Thymus Neoplasms, Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma

In brief

This is a multi-center, open-label, single-arm, prospective interventional study evaluating hypofractionated adjuvant radiotherapy (HART) after radical thymothymectomy in patients with thymic epithelial tumors. The study estimates 5-year local control and prospectively characterizes acute and late treatment-related adverse events, quality of life, cardiopulmonary function, and patterns of failure. Photon therapy and proton therapy are both protocol-acceptable modalities and are selected by shared decision-making rather than randomization.

Key facts

Study ID

NCT07693855

Run by

National Taiwan University Hospital

People needed

69

Starts

2026-08-01

Expected to finish

2035-04-30

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Thymic epithelial tumor, including thymoma or thymic carcinoma, confirmed by pathology.
• Received radical thymothymectomy.
• Masaoka-Koga stage I to III disease with an indication for postoperative radiotherapy.
• Age >= 18 years.
• Karnofsky performance status >= 70%.
• Life expectancy >= 1 year.
• Sufficient bone marrow reserve, renal function, and liver function within 90 days prior to registration, defined as: white blood cell count >= 2000/mm3; platelet count >= 50,000/mm3; hemoglobin >= 8 g/dL; serum creatinine <= 2.0 mg/dL or estimated glomerular filtration rate >= 30 mL/min; AST/ALT <= 2.5 times the upper limit of normal.
• Women of childbearing potential must have a negative qualitative serum or urine pregnancy test within 14 days prior to study entry.
• Able to comply with study procedures and follow-up schedules and willing to provide study-specific informed consent.

You may not qualify if…

• Prior radiotherapy to the thorax.
• Severe active comorbidities that, in the judgment of the investigator, make the patient inappropriate for study entry, interfere with safety or adverse event assessment, or limit compliance with study requirements, including: uncontrolled active infection requiring intravenous antibiotics at registration; transmural myocardial infarction <= 6 months prior to registration; unstable angina or congestive heart failure requiring hospitalization <= 6 months prior to registration; life-threatening uncontrolled clinically significant cardiac arrhythmias; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at registration; uncontrolled psychiatric disorder.
• Planned receipt of another investigational treatment during radiotherapy.
• Planned concurrent chemotherapy during radiotherapy. Prior induction or neoadjuvant chemotherapy, or planned sequential adjuvant chemotherapy after adjuvant radiotherapy, is allowed.
• Pregnant or breastfeeding women.
• Women of childbearing potential and sexually active male participants who are unwilling or unable to use medically acceptable contraception during radiotherapy and for 3 weeks after completing treatment.

Where it is running

• China Medical University Hospital — Taichung, Taiwan
• National Taiwan University Hospital — Taipei, Taiwan
• National Taiwan University Cancer Center — Taipei, Taiwan

Full record on ClinicalTrials.gov

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