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Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
The goal of this prospective, randomized, controlled phase II clinical study is to evaluate the efficacy and safety of neoadjuvant radiotherapy in patients with locally advanced unresectable thymoma. The main questions it aims to answer are: 1. Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ? 2. The safety and adverse reactions of neoadjuvant radiotherapy? Does the addition of neoadjuvant chemotherapy have an impact on this? Participants will be randomly divided into two groups: one group will receive neoadjuvant radiotherapy, and the other will receive neoadjuvant chemoradiotherapy. The primary endpoint of the study is to evaluate the radical resection rate (R0) of two groups. The secondary endpoints will include the pathological complete response rate (pCR), 3-year progression-free survival, and safety and toxicities. In addition, this study will explore the feasibility and completion rate of minimally invasive surgical resection.
Details
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | PHASE2 |
| Status | RECRUITING |
| Enrolment | 178 |
| Start date | Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue May 01 2029 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Locally Advanced Thymoma
Interventions
- neoadjuvant radiotherapy
- cisplatin
Countries
China