Postoperative Hypofractionated Radiotherapy for Stage II/III Thymic Epithelial Tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, single-arm Phase II trial evaluating the safety of adjuvant hypofractionated radiotherapy after complete resection of thymic epithelial tumors. Participants receive a total of 40 Gy in 15 fractions (2.67 Gy per day, 5 days a week for 3 weeks). Primary focus is on treatment-related safety and tolerability, with secondary looks at preliminary efficacy, economic impact, and quality of life. Eligibility includes adults 18-75 with Masaoka-Koga Stage II-III disease, good performance status, and adequate organ function following R0 resection. The study will be conducted at Tianjin Medical University Cancer Institute and Hospital.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Wencheng Zhang, M.D. — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Wencheng Zhang, M.D.
• Email: zhangwencheng@tjmuch.com
• Phone: +86 022 23340123

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using hypofractionated radiotherapy for thymic epithelial tumors

  This study is testing if a shorter, more intense type of radiation therapy can help people with thymic epithelial tumors after surgery feel better and have fewer side effects compared to the standard treatment.

  Recruiting Xiangya Hospital of Central South University · Changsha, Hunan · NCT06692062

• Creating a database for mediastinal tumors at Peking Union Medical College Hospital

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• Carbon ion radiotherapy for thymus tumors after surgery

  This study is testing if carbon ion radiotherapy combined with chemotherapy can help people with advanced thymus tumors feel better and live longer after surgery.

  Recruiting Phase 2 Shanghai Proton and Heavy Ion Center · Shanghai, Shanghai Municipality · NCT06311955

• Using AI to improve diagnosis and recurrence prediction in thymic tumors

  This study is testing if artificial intelligence can help doctors better diagnose thymic tumors and predict the chances of them coming back for patients with these rare cancers.

  Recruiting Erasmus Medical Center · Rotterdam, South Holland · NCT06301945

• Analysis and treatment options for thymic cancers

  This study is trying to find out how genetic changes in thymic cancers can help doctors create better, personalized treatments for patients.

  Recruiting Shanghai Chest Hospital · Shanghai, Shanghai Municipality · NCT05667948

• Using PT-112 to treat thymoma and thymic carcinoma

  This study is testing a new treatment called PT-112 to see if it can help shrink tumors in patients with thymoma and thymic carcinoma who have already tried other chemotherapy.

  Recruiting Phase 2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT05104736

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.