Actively Recruiting
Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-04-24
178
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this prospective, randomized, controlled phase II clinical study is to evaluate the efficacy and safety of neoadjuvant radiotherapy in patients with locally advanced unresectable thymoma. The main questions it aims to answer are: 1. Which treatment method is more effective in improving the radical resection rate: neoadjuvant chemoradiotherapy or neoadjuvant radiotherapy ? 2. The safety and adverse reactions of neoadjuvant radiotherapy? Does the addition of neoadjuvant chemotherapy have an impact on this? Participants will be randomly divided into two groups: one group will receive neoadjuvant radiotherapy, and the other will receive neoadjuvant chemoradiotherapy. The primary endpoint of the study is to evaluate the radical resection rate (R0) of two groups. The secondary endpoints will include the pathological complete response rate (pCR), 3-year progression-free survival, and safety and toxicities. In addition, this study will explore the feasibility and completion rate of minimally invasive surgical resection.
CONDITIONS
Official Title
Neoadjuvant Radiotherapy for Locally Advanced Unresectable Thymoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years to 75 years
- Histologically confirmed thymoma of Masaoka-Koga stage III-IV A
- Assessed as unresectable thymoma by a thoracic surgeon before treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- No prior treatment for thymoma including chemotherapy, radiotherapy, surgery, or immunotherapy
- At least one measurable lesion according to RECIST v1.1
- Cardiopulmonary function suitable for surgery
- Expected survival greater than 3 months
- Completed comprehensive evaluation within 28 days before enrollment, with normal organ and bone marrow function
- Negative pregnancy test for women of childbearing potential within 14 days before enrollment
- Willing to sign informed consent and follow study schedule
You will not qualify if you...
- Histologically confirmed thymic neuroendocrine tumor
- Participation in other interventional clinical studies affecting this study or use of investigational drugs/devices within 4 weeks prior to treatment
- Pregnant or breastfeeding women
- Previous thoracic radiotherapy
- Unsuitable for 3D conformal or intensity-modulated radiotherapy
- History of allogeneic bone marrow or organ transplantation
- History of other malignancies within past 3 years or untreated primary malignancies
- Serious comorbidities affecting treatment
- Any condition or abnormal lab results that could interfere with study completion or results as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Ting Zhang
CONTACT
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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