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Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors (THOR)

14. juli 2026 opdateret af: National Taiwan University Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

69

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Taiwan
      • Taichung, Taiwan
        • China Medical University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Chun-Ru Chien, M.D., Ph.D.
      • Taipei, Taiwan, 100229
        • National Taiwan University Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Chao-Lin Tsai, M.D., Ph.D.
      • Taipei, Taiwan, 106037
        • National Taiwan University Cancer Center
        • Kontakt:
        • Ledende efterforsker:
          • Feng-Ming Hsu, M.D., Ph.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Thymic epithelial tumor, including thymoma or thymic carcinoma, confirmed by pathology.
  2. Received radical thymothymectomy.
  3. Masaoka-Koga stage I to III disease with an indication for postoperative radiotherapy.
  4. Age >= 18 years.
  5. Karnofsky performance status >= 70%.
  6. Life expectancy >= 1 year.
  7. 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.
  8. Women of childbearing potential must have a negative qualitative serum or urine pregnancy test within 14 days prior to study entry.
  9. Able to comply with study procedures and follow-up schedules and willing to provide study-specific informed consent.

Exclusion Criteria:

  1. Prior radiotherapy to the thorax.
  2. 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.
  3. Planned receipt of another investigational treatment during radiotherapy.
  4. Planned concurrent chemotherapy during radiotherapy. Prior induction or neoadjuvant chemotherapy, or planned sequential adjuvant chemotherapy after adjuvant radiotherapy, is allowed.
  5. Pregnant or breastfeeding women.
  6. 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Hypofractionated Adjuvant Radiation Therapy
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.
Stråling: 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.
Stråling: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
5-year local control rate
Tidsramme: 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.
5 years after start of radiotherapy

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-free survival
Tidsramme: Up to 5 years after start of radiotherapy
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
Tidsramme: Up to 5 years after start of radiotherapy
Time from start of radiotherapy to death from any cause.
Up to 5 years after start of radiotherapy
Treatment-related adverse events
Tidsramme: From treatment start through 5 years of follow-up
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
Tidsramme: Baseline and 1, 3, 6, 12, 18, and 24 months after radiotherapy
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
Patterns of failure after disease progression
Tidsramme: Up to 5 years after start of radiotherapy
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
Cardiac function changes
Tidsramme: Baseline through 5 years after radiotherapy
Changes in cardiac sonography (left ventricular ejection fraction [%]) from baseline to post-treatment follow-up time points.
Baseline through 5 years after radiotherapy
Pulmonary function changes
Tidsramme: Baseline through 5 years after radiotherapy
Changes in pulmonary function tests (including FEV1/FVC ratio [%] and DLCO [%]) from baseline to post-treatment follow-up time points.
Baseline through 5 years after radiotherapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taiwan University Hospital

Samarbejdspartnere

National Taiwan University

Efterforskere

  • Studiestol: Feng-Ming Hsu, M.D., Ph.D., National Taiwan University Cancer Center and National Taiwan University Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

30. april 2035

Studieafslutning (Anslået)

30. april 2035

Datoer for studieregistrering

Først indsendt

5. juli 2026

Først indsendt, der opfyldte QC-kriterier

5. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202603115RINE

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