About this trial
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.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed thymic epithelial tumor (thymoma or thymic carcinoma)
Locally advanced, potentially resectable disease (Masaoka-Koga stage III or IVA), as evaluated by a multidisciplinary team (MDT) including thoracic surgery and thoracic oncology
Age 18 to 65 years
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Disqualifiers
Prior chemotherapy, targeted therapy, or immunotherapy for thymic epithelial tumor
Prior thoracic radiation therapy
Active autoimmune disease requiring systemic treatment within the past 2 years
Known hypersensitivity or contraindication to study drugs (cisplatin, epirubicin, etoposide, ifosfamide, or any component of these formulations)
Trial design
Treatments tested in this trial
- Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)
- nab-Paclitaxel and Carboplatin