Phase 3 Trial Comparing Radiotherapy Alone Versus Chemoradiotherapy After Surgery in Thymic Cancer Patients

What this Trial Is About

Researchers are evaluating the role of adjuvant chemotherapy in patients with thymic carcinoma who have undergone complete surgical removal of the tumor. This trial aims to determine whether adding chemotherapy to radiotherapy reduces the chance of the disease progressing and to assess the tolerance of a medium-dose chemotherapy regimen consisting of paclitaxel, cisplatin, and 5-FU. The study compares chemoradiotherapy with radiotherapy alone to address these questions. Participants will be assigned to one of two groups one receiving radiotherapy alone 50 Gy over 25 fractions using IMRT and the other receiving two cycles of chemotherapy followed by radiotherapy and then another two cycles of chemotherapy. The chemotherapy drugs are given intravenously every three weeks at specified doses. This design balances treatment effectiveness with potential side effects. Throughout the study, participants will have regular follow-ups every three months for the first two years, then every six months afterwards. Researchers will monitor disease-free survival over three years as the main outcome, along with overall survival and disease-specific survival. Safety assessments and laboratory tests will be conducted to ensure participants well-being during the trial, which is expected to continue until 2030.

Postoperative Adjuvant Chemotherapy for Thymic Cancer (FUSCC-Thymic 3)