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A Randomized Controlled Trial of 6 Versus 3 Cycles of Neoadjuvant Chemotherapy on Event-Free Survival in Patients With Potentially Resectable Locally Advanced Thymic Epithelial Tumors
This randomized controlled trial compares 6 versus 3 cycles of neoadjuvant chemotherapy in patients with potentially resectable locally advanced thymic epithelial tumors (TETs, WHO type AB/B/C, AJCC TNM stage IIIA-IVA). Patients are randomized 1:1 to receive either 6 or 3 cycles of chemotherapy (cisplatin + doxorubicin + cyclophosphamide for type B; nab-paclitaxel + carboplatin for type C thymoma/thymic carcinoma) every 3 weeks, followed by surgical resection when feasible. The primary endpoint is event-free survival (EFS). The study aims to determine whether extended neoadjuvant chemotherapy improves surgical outcomes and long-term survival in this rare malignancy.
Details
| Lead sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 116 |
| Start date | 2026-03 |
| Completion | 2032-03 |
Conditions
- Thymoma and Thymic Carcinoma
Interventions
- Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)
- nab-Paclitaxel and Carboplatin
Primary outcomes
- Event-Free Survival (EFS) — 3 years from randomization
EFS is defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, incomplete resection (R1/R2), local or distant recurrence after surgery, or death from any cause.
Countries
China