Actively Recruiting
The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor
Led by Jian Chen · Updated on 2025-06-13
55
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To observe the efficacy and toxicities of post-operative (R0/R1) proton radiotherapy for locally advanced primary thymus epithelial malignancies. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was overall survival and cause-specific survival.
CONDITIONS
Official Title
The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with stage II-III (Masaoka-Koga) thymus epithelial malignancies without prior thoracic radiation therapy, who have undergone radical surgery with R0 (no microscopic residual disease) or R1 (microscopic residual disease) resection and have indication for postoperative radiation therapy.
- Signed informed consent.
- Between 18 and 70 years of age.
- ECOG general status score of 0 to 2.
- Expected survival of at least 6 months.
- Adequate organ function including: 1) Blood: ANC 1.5 x 10^9/L, platelet count 80 x 10^9/L, hemoglobin 9 g/dL; 2) Lung: FEV1 > 25%, DLCO > 25%; 3) Cardiac: no severe pulmonary hypertension, cardiovascular, cerebrovascular, peripheral vascular diseases, or serious chronic heart disease affecting radiotherapy; 4) Liver: total bilirubin <1.5 times upper limit of normal, AST and ALT <2 times upper limit; 5) Renal: serum creatinine 1.5 times upper limit or creatinine clearance 50 ml/min, urinary protein <2+ (if urinary protein 2+, 24-hour urine protein 1g).
You will not qualify if you...
- Other uncontrolled malignant tumors.
- Large amounts of pleural or pericardial effusion.
- Particle radiotherapy plans that do not meet target dose coverage or normal tissue dose constraints.
- History of chest radiation therapy or radioactive particle implantation.
- Cardiac pacemakers or metal implants affected by high-energy radiation or dose distribution.
- HIV positive, active hepatitis virus replication requiring but unable to receive antiviral therapy, or active syphilis.
- History of mental illness impeding treatment completion.
- Serious comorbidities interfering with radiotherapy including acute infections, unstable angina, recent heart attack, COPD exacerbations requiring hospitalization, severe immune impairment, diseases with extreme radiation sensitivity, or other conditions affecting particle radiotherapy.
- Other physician-determined reasons making participation inappropriate.
AI-Screening
AI-Powered Screening
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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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