- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07691619
Hypofractionated Radiotherapy After Complete Resection for Stage II/III Thymic Epithelial Tumors (TET-HFRT40)
8. juli 2026 oppdatert av: Tianjin Medical University Cancer Institute and Hospital
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
49
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Wencheng Zhang, M.D.
- Telefonnummer: 1121 +86 022 23340123
- E-post: zhangwencheng@tjmuch.com
Studiesteder
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300060
- Rekruttering
- Tianjin Medical University Cancer Institute and Hospital
-
Ta kontakt med:
- Wencheng Zhang, M.D.
- Telefonnummer: 1121 +86 022 23340123
- E-post: zhangwencheng@tjmuch.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Disease-Free Survival
Tidsramme: 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
Tidsramme: Up to 3 years
|
Time from the start of radiotherapy to death from any cause.
|
Up to 3 years
|
|
Locoregional Recurrence Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Odds Ratios for Cardiac-Related Disease Occurrence According to Predefined Cardiac and Coronary Artery Dose Parameters
Tidsramme: 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.
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From baseline to up to 3 years after radiotherapy
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Wencheng Zhang, M.D., Tianjin Medical University Cancer Institute and Hospital
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
14. juli 2026
Primær fullføring (Antatt)
30. juni 2027
Studiet fullført (Antatt)
30. juni 2029
Datoer for studieregistrering
Først innsendt
1. juli 2026
Først innsendt som oppfylte QC-kriteriene
8. juli 2026
Først lagt ut (Faktiske)
9. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- E20260837
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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