Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hypofractionated Adjuvant Proton Therapy
- Hypofractionated Adjuvant Photon Radiation Therapy
Treatment groups
69 Participants
are divided into 1 treatment groupSponsors and collaborators
National Taiwan University Hospital
Lead sponsor
National Taiwan University
Collaborator
Source ClinicalTrials.gov