Hypofractionated Adjuvant Proton Therapy: Base regimen of 40 Gy (RBE) in 15 fractions or 42.5 Gy (RBE) in 16 fractions. Optional tumor-bed boost of 10 Gy (RBE) in 4 fractions or 16 Gy (RBE) in 6 fractions for R2 macroscopic residual disease may be delivered at investigator discretion if normal tissue constraints are met. Radiation is delivered using Proton pencil-beam scanning IMPT.
Hypofractionated Adjuvant Photon Radiation Therapy: Base regimen of 40 Gy in 15 fractions or 42.5 Gy in 16 fractions. Optional tumor-bed boost of 10 Gy in 4 fractions or 16 Gy in 6 fractions for R2 macroscopic residual disease may be delivered at investigator discretion if normal tissue constraints are met. Treatment is delivered by Photon IMRT/VMAT/RapidArc techniques.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Thymic epithelial tumor, including thymoma or thymic carcinoma, confirmed by pathology.
2. Received radical thymothymectomy.
3. Masaoka-Koga stage I to III disease with an indication for postoperative radiotherapy.
4. Age \>= 18 years.
5. Karnofsky performance status \>= 70%.
6. Life expectancy \>= 1 year.
7. 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.
8. Women of childbearing potential must have a negative qualitative serum or urine pregnancy test within 14 days prior to study entry.
9. Able to comply with study procedures and follow-up schedules and willing to provide study-specific informed consent.
Exclusion Criteria:
1. Prior radiotherapy to the thorax.
2. 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.
3. Planned receipt of another investigational treatment during radiotherapy.
4. Planned concurrent chemotherapy during radiotherapy. Prior induction or neoadjuvant chemotherapy, or planned sequential adjuvant chemotherapy after adjuvant radiotherapy, is allowed.
5. Pregnant or breastfeeding women.
6. 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.
Primary outcome measure(s)
5-year local control rate — 5 years after start of radiotherapy Local control is defined as absence of radiologically or pathologically confirmed tumor recurrence within the original tumor bed or adjacent mediastinal region.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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