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
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 2
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Wencheng Zhang, M.D.
- Numero di telefono: 1121 +86 022 23340123
- Email: zhangwencheng@tjmuch.com
Luoghi di studio
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Cina, 300060
- Reclutamento
- Tianjin Medical University Cancer Institute and Hospital
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Contatto:
- Wencheng Zhang, M.D.
- Numero di telefono: 1121 +86 022 23340123
- Email: zhangwencheng@tjmuch.com
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-
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- 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.
- Age 18-75 years, male or female.
- 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.
- Eastern Cooperative Oncology Group performance status of 0-1.
- Life expectancy of at least 3 months.
- Adequate major organ function to meet the requirements of study treatment, including bone marrow, hepatic, renal, and coagulation function according to protocol-specified criteria.
- 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:
- Patients who do not meet the protocol-specified requirements for pathological type, disease stage, or histological subtype.
- Patients who have not undergone surgical treatment, or who underwent R1 or R2 resection, or who have definite gross residual disease.
- Prior thoracic radiotherapy.
- Major surgery other than the tumor resection procedure or severe trauma within 4 weeks before the first radiotherapy treatment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Prior or ongoing non-protocol-specified antitumor therapy, including immunotherapy, targeted therapy, radiotherapy, or other investigational treatment.
- Active autoimmune disease or a history of severe autoimmune disease that, in the investigator's judgment, makes the patient unsuitable for radiotherapy.
- History of immunodeficiency, including HIV positivity, history of organ transplantation, or history of allogeneic bone marrow transplantation.
- 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.
- Severe infection within 4 weeks before the first radiotherapy treatment, or active pulmonary inflammation indicated by baseline imaging.
- History of interstitial lung disease, history of non-infectious pneumonitis, or Grade 3 or higher pulmonary dysfunction confirmed by pulmonary function testing.
- Active pulmonary tuberculosis, active hepatitis B infection, or active hepatitis C infection.
- Diagnosis of another malignancy before the first radiotherapy treatment, except for low-risk malignancies that have been adequately treated.
- Any other condition that, in the investigator's judgment, may affect patient safety, compliance, or the collection of study data.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
|---|---|
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Sperimentale: RT
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
Lasso di tempo: Up to 3 months
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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).
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Up to 3 months
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Disease-Free Survival
Lasso di tempo: Up to 3 years
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Time from the start of radiotherapy to the first documented disease recurrence, distant metastasis, or death from any cause, whichever occurs first.
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Up to 3 years
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Overall Survival
Lasso di tempo: Up to 3 years
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Time from the start of radiotherapy to death from any cause.
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Up to 3 years
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Locoregional Recurrence Rate
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
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Distant Metastasis Rate
Lasso di tempo: Up to 3 years
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Percentage of participants who develop distant metastasis during follow-up, as assessed by imaging, pathology, or clinical evaluation.
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Up to 3 years
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All-Cause Mortality Rate
Lasso di tempo: Up to 3 years
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Percentage of participants who die from any cause during follow-up.
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Up to 3 years
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Incidence of Treatment-Related Late Adverse Events
Lasso di tempo: From 6 months after completion of radiotherapy to 3 years
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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.
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From 6 months after completion of radiotherapy to 3 years
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Total Economic Cost
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
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Quality of Life Score Assessed by EORTC QLQ-C30
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
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Swallowing Function Score Assessed by the Standardized Swallowing
Lasso di tempo: Up to 3 years
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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.
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Up to 3 years
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Altre misure di risultato
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
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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.
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From baseline to up to 3 years after radiotherapy
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Wencheng Zhang, M.D., Tianjin Medical University Cancer Institute and Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- E20260837
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