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Hypofractionated Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors (TET-HFRT40)

A Prospective, Single-Arm Phase II Clinical Study of Hypofractionated Adjuvant Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors

This is a prospective, open-label, single-arm Phase II study designed to evaluate the safety of postoperative hypofractionated radiotherapy in patients with Stage II/III thymic epithelial tumors after complete resection. After a screening period of up to 28 days, eligible patients will receive adjuvant hypofractionated radiotherapy to a total dose of 40 Gy in 15 fractions, delivered once daily at 2.67 Gy per fraction, 5 days per week over 3 weeks. The study will primarily assess treatment-related safety and tolerability, with preliminary evaluation of efficacy, economic burden, and quality of life.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

49

Fase

  • Fase 2

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

    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Cina, 300060
        • Reclutamento
        • Tianjin Medical University Cancer Institute and Hospital
        • Contatto:

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. Patients who voluntarily agree to participate in this study, sign the informed consent form, demonstrate good compliance, and are willing to comply with scheduled follow-up visits.
  2. Age 18-75 years, male or female.
  3. Histopathologically confirmed thymoma or thymic carcinoma after R0 complete resection. Eligible disease stages according to the Masaoka-Koga staging system include Stage II-III thymic carcinoma, Stage IIA Type B3 thymoma, Stage IIB Type B2/B3 thymoma, and Stage III thymoma.
  4. Eastern Cooperative Oncology Group performance status of 0-1.
  5. Life expectancy of at least 3 months.
  6. Adequate major organ function to meet the requirements of study treatment, including bone marrow, hepatic, renal, and coagulation function according to protocol-specified criteria.
  7. Patients with reproductive potential must agree to use medically acceptable contraception during study treatment and for 6 months after completion of study treatment. Female patients of childbearing potential must have a negative pregnancy test before enrollment and must not be breastfeeding.

Exclusion Criteria:

  1. Patients who do not meet the protocol-specified requirements for pathological type, disease stage, or histological subtype.
  2. Patients who have not undergone surgical treatment, or who underwent R1 or R2 resection, or who have definite gross residual disease.
  3. Prior thoracic radiotherapy.
  4. Major surgery other than the tumor resection procedure or severe trauma within 4 weeks before the first radiotherapy treatment.
  5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  6. Prior or ongoing non-protocol-specified antitumor therapy, including immunotherapy, targeted therapy, radiotherapy, or other investigational treatment.
  7. Active autoimmune disease or a history of severe autoimmune disease that, in the investigator's judgment, makes the patient unsuitable for radiotherapy.
  8. History of immunodeficiency, including HIV positivity, history of organ transplantation, or history of allogeneic bone marrow transplantation.
  9. Uncontrolled severe cardiovascular disease, such as New York Heart Association Class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or severe arrhythmia requiring clinical intervention.
  10. Severe infection within 4 weeks before the first radiotherapy treatment, or active pulmonary inflammation indicated by baseline imaging.
  11. History of interstitial lung disease, history of non-infectious pneumonitis, or Grade 3 or higher pulmonary dysfunction confirmed by pulmonary function testing.
  12. Active pulmonary tuberculosis, active hepatitis B infection, or active hepatitis C infection.
  13. Diagnosis of another malignancy before the first radiotherapy treatment, except for low-risk malignancies that have been adequately treated.
  14. Any other condition that, in the investigator's judgment, may affect patient safety, compliance, or the collection of study data.

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: RT
The investigational treatment consists of postoperative hypofractionated radiotherapy delivered at a total dose of 40 Gy in 15 fractions (2.67 Gy per fraction), administered 5 days per week.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
Lasso di tempo: Up to 3 months
Percentage of participants who experience treatment-related Grade 2 or higher acute adverse events from the start of radiotherapy to 3 months after completion of radiotherapy, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
Up to 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease-Free Survival
Lasso di tempo: Up to 3 years
Time from the start of radiotherapy to the first documented disease recurrence, distant metastasis, or death from any cause, whichever occurs first.
Up to 3 years
Overall Survival
Lasso di tempo: Up to 3 years
Time from the start of radiotherapy to death from any cause.
Up to 3 years
Locoregional Recurrence Rate
Lasso di tempo: Up to 3 years
ercentage of participants who develop locoregional recurrence during follow-up. Locoregional recurrence includes recurrence in the tumor bed, mediastinum, pleura, or regional lymph nodes, as assessed by imaging, pathology, or clinical evaluation.
Up to 3 years
Distant Metastasis Rate
Lasso di tempo: Up to 3 years
Percentage of participants who develop distant metastasis during follow-up, as assessed by imaging, pathology, or clinical evaluation.
Up to 3 years
All-Cause Mortality Rate
Lasso di tempo: Up to 3 years
Percentage of participants who die from any cause during follow-up.
Up to 3 years
Incidence of Treatment-Related Late Adverse Events
Lasso di tempo: From 6 months after completion of radiotherapy to 3 years
Percentage of participants who experience treatment-related late adverse events occurring 6 months or later after completion of radiotherapy, including pulmonary, cardiac, esophageal, or other late adverse events, assessed according to NCI-CTCAE v5.0.
From 6 months after completion of radiotherapy to 3 years
Total Economic Cost
Lasso di tempo: Up to 3 years
Total economic cost per participant during the study period, including direct medical costs, non-medical costs, and indirect costs. Direct medical costs include radiotherapy costs, radiotherapy-related symptomatic treatment costs, and costs for the management of toxic and adverse reactions. Non-medical and indirect costs include transportation costs, accommodation costs, and lost work or companion time costs. Costs will be calculated in Chinese Yuan.
Up to 3 years
Quality of Life Score Assessed by EORTC QLQ-C30
Lasso di tempo: Up to 3 years
Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status/quality of life score will be recorded at baseline and predefined follow-up visits. Scores range from 0 to 100, with higher scores indicating better global health status/quality of life.
Up to 3 years
Swallowing Function Score Assessed by the Standardized Swallowing
Lasso di tempo: Up to 3 years
Swallowing function will be assessed using the Standardized Swallowing Assessment (SSA). The total SSA score will be recorded at baseline and predefined follow-up visits, with higher scores indicating worse swallowing function.
Up to 3 years

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Odds Ratios for Cardiac-Related Disease Occurrence According to Predefined Cardiac and Coronary Artery Dose Parameters
Lasso di tempo: From baseline to up to 3 years after radiotherapy
Odds ratios for cardiac-related disease occurrence per 1-Gy increase in predefined cardiac and coronary artery dose parameters will be estimated using logistic regression. Predefined dose parameters will include mean heart dose and coronary artery substructure dose parameters, measured in Gray (Gy) from the radiotherapy treatment plan. Cardiac-related disease occurrence will be defined as the occurrence of clinically diagnosed cardiac disease or cardiac adverse events during follow-up, assessed by clinical cardiac evaluation and NCI-CTCAE v5.0. Cardiac-related diseases or adverse events may include coronary artery disease, myocardial ischemia or infarction, arrhythmia, heart failure, pericardial disease, or other clinically diagnosed cardiac events.
From baseline to up to 3 years after radiotherapy

Collaboratori e investigatori

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

Sponsor

Investigatori

  • Investigatore principale: Wencheng Zhang, M.D., Tianjin Medical University Cancer Institute and 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)

14 luglio 2026

Completamento primario (Stimato)

30 giugno 2027

Completamento dello studio (Stimato)

30 giugno 2029

Date di iscrizione allo studio

Primo inviato

1 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

9 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • E20260837

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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

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 .