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Hypofractionated Adjuvant Radiotherapy for Thymic Epithelial Tumors (THOR)

14 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

69

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Radiazione: 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.
Radiazione: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
5-year local control rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Taiwan University Hospital

Collaboratori

National Taiwan University

Investigatori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

30 aprile 2035

Completamento dello studio (Stimato)

30 aprile 2035

Date di iscrizione allo studio

Primo inviato

5 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202603115RINE

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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