Phase 2 Study of Methylprednisolone with Chemoradiotherapy for Treating Unresectable or Recurrent Thymoma

What this Trial Is About

This clinical trial investigates the use of methylprednisolone combined with concurrent chemoradiotherapy to treat patients with unresectable or recurrent thymoma confined to the chest and neck area. The study focuses on patients diagnosed with specific types of thymoma type AB or B1-3 who have measurable disease and meet certain health and age criteria. The trial aims to evaluate how well this combined treatment works in managing the disease. Participants will receive hypofractionated radiotherapy along with weekly chemotherapy using albumin-bound paclitaxel and cisplatin. Alongside these treatments, methylprednisolone will be given daily at a dose of 2 mg per kg of body weight throughout the radiotherapy period. This approach is designed to assess the treatment combinations effect on thymoma in a single-arm, phase II study. During the study, participants will be monitored for tumor response one to two months after treatment, as well as progression-free survival, overall survival, treatment-related toxicities, and quality of life over a two-year and one-year period, respectively. Researchers will conduct various assessments including clinical evaluations and safety monitoring to gather data on the treatments impact and side effects. Total participation length and follow-up will extend for at least two years post-treatment.

Glucocorticoids Combined With Concurrent Chemoradiotherapy for Unresectable Thymoma