Actively Recruiting
Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor
Led by Jian Chen · Updated on 2025-06-13
48
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.
CONDITIONS
Official Title
Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage II-IV (Masaoka-Koga) thymic epithelial malignancies without previous thoracic radiotherapy who had radical surgery with visible residual tumor (R2 resection) and confirmed pathological diagnosis
- Signed informed consent
- Aged between 18 and 70 years
- ECOG performance status score of 0 to 2
- Expected survival of at least 6 months
- Adequate organ function including: (1) Blood counts with ANC ≥1.5 x 10^9/L, platelets ≥80 x 10^9/L, hemoglobin ≥9 g/dL; (2) Lung function with FEV1 >25%, DLCO >25%; (3) Heart function without serious pulmonary hypertension, cardiovascular or cerebrovascular disease, peripheral vascular disease, or other serious heart conditions affecting radiotherapy; (4) Liver function with total bilirubin <1.5 times upper normal limit, AST and ALT <2 times upper normal limit; (5) Kidney function with serum creatinine ≤1.5 times upper normal limit or creatinine clearance ≥50 ml/min, and urinary protein less than 2+ (if baseline urinary protein is ≥2+, 24-hour urine protein must be ≤1g)
You will not qualify if you...
- Presence of uncontrolled other malignant tumors
- Large amounts of pleural or pericardial effusion
- Inability to meet minimum radiotherapy dose coverage or normal tissue dose constraints
- History of chest radiation therapy or radioactive particle implantation
- Presence of cardiac pacemakers or internal metal prostheses affecting radiation
- Pregnancy or lactation
- HIV positive status, active hepatitis requiring antiviral therapy but unable to receive it, or active syphilis
- History of mental illness interfering with treatment completion
- Serious comorbidities interfering with radiotherapy, including acute infections, recent unstable angina or heart failure hospitalization within 6 months, severe respiratory conditions requiring hospitalization, severely impaired immune function, diseases highly sensitive to radiation like ataxia telangiectasia, or other conditions affecting particle radiotherapy
- Other conditions deemed inappropriate by the physician for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China, 201513
Actively Recruiting
Research Team
J
Jing Li
CONTACT
K
Kun Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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