Actively Recruiting
An Open-label, Multi-center, Randomized Study of Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Led by Fudan University · Updated on 2026-04-24
238
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether adding radiotherapy after complete surgical removal improves survival in patients with stage II or III thymoma. This study aims to clarify the benefit of adjuvant radiotherapy since previous research shows better outcomes with complete resection but the role of additional radiotherapy remains unclear. The trial is sponsored by Fudan University and focuses on patients with this specific type and stage of thymoma. Participants are randomly assigned to one of two groups: one group receives adjuvant radiotherapy delivering a total of 50Gy divided into 25 sessions after their complete tumor removal, while the other group undergoes complete resection alone without further treatment. This open-label, multi-center trial compares these approaches to assess their impact on survival. Throughout the study, participants will be monitored for disease-free survival over five years as the main outcome. Secondary measures include overall survival and tracking any treatment-related side effects using standard criteria. Patients will undergo regular follow-ups and evaluations to assess their health status and treatment effects during this period, which lasts up to five years after enrollment.
CONDITIONS
Brief Title
Adjuvant Radiotherapy for Stage II/III Thymoma After Complete Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Pathologically confirmed Masaoka stage II or III thymoma
- Adequate bone marrow, liver, and kidney function
- Complete tumor resection done within the last 3 months
- Signed written informed consent
You will not qualify if you...
- Presence of distant metastases
- Previous radiotherapy or chemotherapy
- History of malignancy in the past five years excluding cervical carcinoma in situ
- Active clinical lung infection
- Pregnant or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 weeks
Participants receive adjuvant radiotherapy after complete tumor resection or are observed without additional intervention.
25 visits for radiotherapy sessions
Duration - Up to 5 years
Participants are monitored for disease-free survival, overall survival, and treatment-related adverse events for up to 5 years after treatment.
Regular follow-up visits during 5 years
Trial Site Locations
Total: 1 location
1
Kailiang Wu
Shanghai, Shanghai Municipality, China, 20032
Actively Recruiting
Research Team
K
Kailiang Wu, MD.PhD.
X
Xingwen Fan, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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