Neoadjuvant radiotherapy for unresectable thymoma

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 clinical trial evaluates the efficacy and safety of neoadjuvant radiotherapy in patients with locally advanced unresectable thymoma. Participants will be randomly assigned to receive either neoadjuvant radiotherapy alone or neoadjuvant chemoradiotherapy. The primary goal is to determine which treatment method improves the radical resection rate, while secondary endpoints include assessing the pathological complete response rate, progression-free survival, and safety profiles. The study aims to provide clearer guidance on optimal neoadjuvant treatment protocols for thymoma patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged ≥18 years and ≤75 years.
* Histologically confirmed thymoma of Masaoka-Koga stage III-IV A.
* Assessed as unresectable thymoma by a thoracic surgeon prior to treatment.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* No prior anti-thymoma treatment, including but not limited to systemic chemotherapy, radiotherapy, surgery, or immunotherapy.
* Presence of at least one measurable lesion according to RECIST v1.1 criteria.
* Cardiopulmonary function compatible with surgery.
* Expected survival of \>3 months.
* Comprehensive evaluation completed within 28 days before enrollment in the study, with a full blood cell test obtained within 15 days, demonstrating normal visceral organ function and normal bone marrow function.
* Negative serum or urine pregnancy test for women of childbearing potential within 14 days before study enrollment.
* Willingness of the patient to sign an informed consent form and to adhere to the specified follow-up schedule.

Exclusion Criteria:

* Histologically confirmed thymic neuroendocrine tumor.
* Currently participating in an interventional clinical study that may affect this study, or having received other investigational drugs or devices within 4 weeks prior to the first treatment in this study.
* Pregnant or breastfeeding women.
* Previous history of thoracic radiotherapy.
* Deemed unsuitable for three-dimensional conformal or intensity-modulated radiotherapy by a radiation oncology specialist.
* History of allogeneic bone marrow or organ transplantation.
* History of malignancies other than thymoma within the past 3 years, or untreated other primary malignancies.
* Serious comorbidities that would affect the study treatment.
* Any history or evidence of disease, treatment, or abnormal laboratory values that could interfere with the study results or prevent the participant from completing the study, or other situations deemed unsuitable for enrollment by the investigator.

Where it's running

• The Second Affiliated Hospital of Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Ting Zhang
• Email: zezht@zju.edu.cn
• Phone: +86-571-87783521

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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.