Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Taiwan University | OTHER |
Not provided
Not provided
Not provided
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.
Patients with pathologically confirmed thymic epithelial tumors, including thymoma and thymic carcinoma, who have undergone radical thymothymectomy and have an indication for postoperative radiotherapy will receive hypofractionated adjuvant radiotherapy. Base regimens are 40 Gy (RBE) in 15 fractions or 42.5 Gy (RBE) in 16 fractions. For patients with incomplete resection, close margins, residual disease, or other high-risk tumor-bed features, an optional tumor-bed boost may be delivered at investigator discretion, using 10 Gy (RBE) in 4 fractions or, for R2 macroscopic residual disease, 16 Gy (RBE) in 6 fractions. Treatment is delivered once per workday over approximately 3 to 4 weeks, with an additional 1 to 2 weeks if boost is delivered.
Photon therapy with IMRT or VMAT/RapidArc and proton therapy with pencil-beam scanning IMPT are both allowed. Mixed photon and proton treatment courses are not allowed. Target volumes include the mediastinal tumor bed, with pleural or pericardial tumor bed coverage when clinically indicated. Routine elective irradiation of uninvolved mediastinal lymph node stations is not allowed.
Participants are followed at baseline, during treatment, and after treatment at 1, 3, and 6 months, every 6 months through 2 years, and then annually until progression, death, or completion of protocol-specified follow-up. Assessments include clinical evaluation, adverse event assessment using CTCAE version 6.0, CT imaging assessed using RECIST 1.1, pulmonary function testing, cardiac sonography and electrocardiography, EORTC QLQ-C30, and protocol-specified dosimetric analyses.
The primary efficacy analysis uses a Bayesian beta-binomial model for the 5-year local control rate. The study requires 55 evaluable patients, with a total accrual goal of 69 patients to account for approximately 20 percent attrition. Safety monitoring includes semiannual interim reports, annual reports to the ethics committee, and stopping rules for excessive serious adverse events related to the intervention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated Adjuvant Radiation Therapy | Experimental | Participants receive hypofractionated adjuvant radiotherapy after radical thymothymectomy. Photon therapy or proton therapy is selected by shared decision-making between the participant and treating radiation oncologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Adjuvant Proton Therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year local control rate | Local control is defined as absence of radiologically or pathologically confirmed tumor recurrence within the original tumor bed or adjacent mediastinal region. | 5 years after start of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Time from start of radiotherapy to first documented disease progression, including local, regional, or distant progression, or death from any cause. | Up to 5 years after start of radiotherapy |
| Overall survival |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng-Ming Hsu, M.D., Ph.D. | Contact | +886-23123456 | 67061 | hsufengming@ntuh.gov.tw |
| Name | Affiliation | Role |
|---|---|---|
| Feng-Ming Hsu, M.D., Ph.D. | National Taiwan University Cancer Center and National Taiwan University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Hospital | Taichung | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013953 | Thymus Neoplasms |
| C536905 | Thymic epithelial tumor |
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
Not provided
Not provided
Single-arm study of hypofractionated adjuvant radiotherapy after radical thymothymectomy; photon or proton modality is selected by shared decision-making and is not randomized.
Not provided
Not provided
Not provided
Not provided
|
| Hypofractionated Adjuvant Photon Radiation Therapy | Radiation | 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. |
|
Time from start of radiotherapy to death from any cause.
| Up to 5 years after start of radiotherapy |
| Treatment-related adverse events | Acute and late treatment-related adverse events graded using CTCAE version 6.0, including grade 2 or higher and grade 3 or higher events, with attention to radiation pneumonitis, esophagitis, and cardiac events. | From treatment start through 5 years of follow-up |
| Health-related quality of life | EORTC QLQ-C30 Taiwanese Mandarin version scores, transformed to a 0 to 100 scale according to EORTC guidelines. | Baseline and 1, 3, 6, 12, 18, and 24 months after radiotherapy |
| Cardiac and pulmonary function changes | Changes in pulmonary function tests, cardiac sonography, and electrocardiography from baseline to post-treatment follow-up time points. | Baseline through 5 years after radiotherapy |
| Patterns of failure after disease progression | Patterns of disease failure after progression, including local, regional, distant, pleural, or pericardial recurrence patterns as assessed by protocol-specified imaging and clinical review. | Up to 5 years after start of radiotherapy |
| Exploratory comparison of photon and proton therapy outcomes | Exploratory comparison of baseline characteristics, local control, survival, toxicity, quality of life, cardiopulmonary function, and dosimetric endpoints between patients treated with photon therapy and proton therapy. | Up to 5 years after start of radiotherapy |
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
|
| National Taiwan University Cancer Center | Taipei | 106037 | Taiwan |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |