Neoadjuvant radiotherapy for unresectable thymoma
A Prospective, Randomized, Controlled Phase Ⅱ Clinical Trial of Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
This study is testing if giving radiation therapy before surgery helps people with advanced thymoma have better outcomes compared to combining it with chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06924619 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed Masaoka-Koga stage III-IV A thymoma deemed unresectable by a thoracic surgeon.
Not a fit: Patients with prior anti-thymoma treatments or those with other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and survival rates for patients with locally advanced unresectable thymoma.
How similar studies have performed: Previous retrospective studies have suggested that neoadjuvant radiotherapy can achieve significant resection rates, but this approach is still being evaluated in a randomized controlled setting.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.