Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors
NCT07693855 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2026-07-16
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.
Conditions
- Thymoma
- Thymus Neoplasms
- Thymic Epithelial Tumor
- Thymic Carcinoma
Interventions
- RADIATION
-
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.
- RADIATION
-
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.
Sponsors & Collaborators
-
National Taiwan University
collaborator OTHER -
National Taiwan University Hospital
lead OTHER
Principal Investigators
-
Feng-Ming Hsu, M.D., Ph.D. · National Taiwan University Cancer Center and National Taiwan University Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2035-04-30
- Completion
- 2035-04-30
Countries
- Taiwan
Study Locations
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