Actively Recruiting
Prospective Phase II Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymic Epithelial Malignant Tumor Received R2 Resection
Led by Jian Chen · Updated on 2025-06-13
48
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of carbon ion radiotherapy combined with platinum-based chemotherapy in patients who have locally advanced or advanced thymic epithelial malignant tumors with visible residual tumor after surgery (R2 resection). This phase II clinical study aims to observe the effectiveness and side effects of this treatment approach. The main focus is on progression-free survival and treatment-related toxicities, with additional measures including local relapse-free survival, overall survival, and cause-specific survival. Participants will receive carbon ion radiotherapy totaling 72 GyE, delivered in 18 fractions. Alongside this, patients will undergo at least four cycles of platinum-based chemotherapy regimens, which may include combinations such as etoposide with cisplatin, paclitaxel with cisplatin, or docetaxel with various platinum agents. The treatment regimen is carefully structured to combine radiation and chemotherapy for thorough management of thymus cancer. During the study, patients will be monitored regularly for disease progression and any adverse effects from treatment. Follow-up assessments will include clinical evaluations every 3 to 4 months for the first two years, then every 6 months from years 3 to 5, and annually thereafter, up to 100 months. Researchers will track survival rates and tumor progression to understand long-term outcomes. The total participation duration may extend up to several years due to extended monitoring.
CONDITIONS
Brief 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 aged 18 to 70 years
- Diagnosed with stage II-IV (Masaoka-Koga) thymic epithelial malignancies
- Underwent radical surgery with visible residual tumor (R2 resection)
- Have a definite pathological diagnosis
- Signed informed consent
- ECOG performance status score between 0 and 2
- Expected survival of at least 6 months
- Adequate organ function including blood, lung, cardiac, liver, and renal function as specified
You will not qualify if you...
- Having uncontrolled other malignant tumors
- Presence of large pleural or pericardial effusion
- Unable to meet particle radiotherapy dose coverage or normal tissue dose constraints
- History of chest radiation therapy or radioactive particle implantation
- Presence of cardiac pacemakers or internal metal implants affecting radiation
- Pregnancy or lactation
- HIV positive or active hepatitis requiring but unable to receive antiviral therapy
- Active syphilis
- History of mental illness interfering with treatment
- Serious comorbidities interfering with radiotherapy including acute infections, recent heart issues, severe respiratory conditions, impaired immune function, radiation-sensitive diseases, or other relevant illnesses
- Any other condition deemed inappropriate by the physician for study participation
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.
1 visit (in-person)
Duration - Radiotherapy delivered in 18 fractions; chemotherapy for at least 4 cycles
Participants receive postoperative carbon ion radiotherapy combined with a platinum-based chemotherapy regimen for thymus tumor with residual tumor.
Multiple visits for radiotherapy and chemotherapy sessions over several weeks
Duration - Up to 100 months after radiotherapy started
Participants are monitored for disease progression, treatment-related adverse events, and survival outcomes.
Visits every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter
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
K
Kun Liu
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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