Thymus NeoplasmsTHORNCT07693855
Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors
A study testing Hypofractionated Adjuvant Proton Therapy and Hypofractionated Adjuvant Photon Radiation Therapy in people with Thymus Neoplasms and Thymic Epithelial Tumor, run by National Taiwan University Hospital at 3 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thymus Neoplasms, Thymic Epithelial Tumor, Thymoma
- What is being tested?
- Hypofractionated Adjuvant Proton Therapy and Hypofractionated Adjuvant Photon Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesTaiwan
- Study dates
- 1 Aug 2026to 30 Apr 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan3 sites
China Medical University Hospital
Taichung
Study Contact, +886-42205-2121 ext. 17450, 094872@tool.caaumed.org.tw
Chun-Ru Chien, M.D., Ph.D.
National Taiwan University Hospital
Taipei, 100229
Study Contact, +886-22312-3456 ext. 262643, dr.hsufm@gmail.com
Chao-Lin Tsai, M.D., Ph.D.
National Taiwan University Cancer Center
Taipei, 106037
Study Contact, +886-22322-0322 ext. 231600, A01450@ntucc.gov.tw
Feng-Ming Hsu, M.D., Ph.D.
About this study
Official title: Thymic Epithelial Tumor Hypofractionated Adjuvant Radiotherapy (THOR): A Multi-center Single-Arm Prospective Clinical 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.
Read the detailed description
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.
- Conditions
- Thymus Neoplasms, Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma
- Being tested
- Hypofractionated Adjuvant Proton Therapy, Hypofractionated Adjuvant Photon Radiation Therapy
- Keywords
- adverse events, thymoma, thymic carcinoma, clinical trial, thymic epithelial tumors, multicenter, health-related quality of life, postoperative radiotherapy, hypofractionation, proton radiotherapy
- Medical subject headings
- Thymus Neoplasms, Thymic epithelial tumor, Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated Adjuvant Proton TherapyRadiation
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 TherapyRadiation
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Hypofractionated Adjuvant Proton Therapy; Radiation: Hypofractionated Adjuvant Photon Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years after start of radiotherapy
Secondary outcomes (7)
Progression-free survival
Time from start of radiotherapy to first documented disease progression, including local, regional, or distant progression, or death from any cause.
Measured: Up to 5 years after start of radiotherapy
Overall survival
Time from start of radiotherapy to death from any cause.
Measured: 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.
Measured: 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.
Measured: Baseline and 1, 3, 6, 12, 18, and 24 months after radiotherapy
Cardiac function changes
Changes in cardiac sonography (left ventricular ejection fraction [%]) from baseline to post-treatment follow-up time points.
Measured: Baseline through 5 years after radiotherapy
Pulmonary function changes
Changes in pulmonary function tests (including FEV1/FVC ratio [%] and DLCO [%]) from baseline to post-treatment follow-up time points.
Measured: 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.
Measured: Up to 5 years after start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2035 (estimated)
- Study completion30 Apr 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymus NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm study of hypofractionated adjuvant radiotherapy after radical thymothymectomy; photon or proton modality is selected by shared decision-making and is not randomized.
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, M.D., Ph.D., Study chair, National Taiwan University Cancer Center and National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693855
- Sponsor's protocol ID
- 202603115RINE
- Acronym
- THOR
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymic Epithelial Tumor Hypofractionated Adjuvant Radiotherapy (THOR): A Multi-center Single-Arm Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07693855
- Acronym / sponsor ID
- THOR / 202603115RINE
- Conditions
- Thymus Neoplasms, Thymic Epithelial Tumor, Thymoma, Thymic Carcinoma
- Keywords
- adverse events, thymoma, thymic carcinoma, clinical trial, thymic epithelial tumors, multicenter, health-related quality of life, postoperative radiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2035 (estimated)
- Study completion
- 30 Apr 2035 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study of hypofractionated adjuvant radiotherapy after radical thymothymectomy; photon or proton modality is selected by shared decision-making and is not randomized.
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated Adjuvant Radiation Therapy | Experimental | Radiation: Hypofractionated Adjuvant Proton Therapy, Radiation: Hypofractionated Adjuvant Photon Radiation TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated Adjuvant Proton TherapyBase 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 Radiation Therapy |
| Hypofractionated Adjuvant Photon Radiation TherapyBase 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. | Radiation | Hypofractionated Adjuvant Radiation Therapy |
Primary outcome
5-year local control rate
Time frame: 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.
7 secondary outcomes
Progression-free survival
Time frame: Up to 5 years after start of radiotherapy
Overall survival
Time frame: Up to 5 years after start of radiotherapy
Treatment-related adverse events
Time frame: From treatment start through 5 years of follow-up
Health-related quality of life
Time frame: Baseline and 1, 3, 6, 12, 18, and 24 months after radiotherapy
Cardiac function changes
Time frame: Baseline through 5 years after radiotherapy
Pulmonary function changes
Time frame: Baseline through 5 years after radiotherapy
Patterns of failure after disease progression
Time frame: Up to 5 years after start of radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Thymus Neoplasms
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
Active, not recruitingPhase 1
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
Carcinoma, Non-Small-Cell Lung, Cutaneous Melanoma
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng-Ming Hsu, M.D., Ph.D. study chair
National Taiwan University Cancer Center and National Taiwan University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypofractionated Adjuvant Proton Therapy and Hypofractionated Adjuvant Photon Radiation Therapy in people with Thymus Neoplasms and Thymic Epithelial Tumor, run by National Taiwan University Hospital at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng-Ming Hsu, M.D., Ph.D. (+886-23123456 ext. 67061, hsufengming@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year local control rate (time frame: 5 years after start of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.