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

2026년 7월 8일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

49

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, 중국, 300060
        • 모병
        • Tianjin Medical University Cancer Institute and Hospital
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: RT
방사능: Postoperative hypo-fractionated radiotherapy
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Treatment-Related Grade 2 or Higher Acute Adverse Events
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Disease-Free Survival
기간: 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
기간: Up to 3 years
Time from the start of radiotherapy to death from any cause.
Up to 3 years
Locoregional Recurrence Rate
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Odds Ratios for Cardiac-Related Disease Occurrence According to Predefined Cardiac and Coronary Artery Dose Parameters
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Tianjin Medical University Cancer Institute and Hospital

수사관

  • 수석 연구원: Wencheng Zhang, M.D., Tianjin Medical University Cancer Institute and Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 14일

기본 완료 (추정된)

2027년 6월 30일

연구 완료 (추정된)

2029년 6월 30일

연구 등록 날짜

최초 제출

2026년 7월 1일

QC 기준을 충족하는 최초 제출

2026년 7월 8일

처음 게시됨 (실제)

2026년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 8일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • E20260837

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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