Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors

NCT07693855 | Not Yet Recruiting DMC

• 1 other identifier: 202603115RINE
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief 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

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; hypofractionation; proton radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Progression-free survival

  Up to 5 years after start of radiotherapy

• Overall survival

  Up to 5 years after start of radiotherapy

• Treatment-related adverse events

  From treatment start through 5 years of follow-up

• Health-related quality of life

  Baseline and 1, 3, 6, 12, 18, and 24 months after radiotherapy

• Cardiac function changes

  Baseline through 5 years after radiotherapy

Study Arms (1)

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.

Radiation: Hypofractionated Adjuvant Proton Therapy; Radiation: Hypofractionated Adjuvant Photon Radiation Therapy

Interventions

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.

Hypofractionated Adjuvant Radiation Therapy

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.

Hypofractionated Adjuvant Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University: collaborator
• National Taiwan University Hospital: lead

Study Sites (3)

China Medical University Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, 100229, Taiwan

Location

National Taiwan University Cancer Center

Taipei, 106037, Taiwan

Location

MeSH Terms

Conditions

Thymus Neoplasms; Thymic epithelial tumor; Thymoma

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type

Study Officials

• Feng-Ming Hsu, M.D., Ph.D.

  National Taiwan University Cancer Center and National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Feng-Ming Hsu, M.D., Ph.D.

CONTACT

+886-23123456; hsufengming@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm study of hypofractionated adjuvant radiotherapy after radical thymothymectomy; photon or proton modality is selected by shared decision-making and is not randomized.

Study Record Dates

• First Submitted: July 5, 2026
• First Posted: July 9, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): April 30, 2035
• Study Completion (Estimated): April 30, 2035
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

TW (3)