Carbon ion radiotherapy for thymus tumors after surgery

Prospective Phase II Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymic Epithelial Malignant Tumor Received R2 Resection

This study is testing if carbon ion radiotherapy combined with chemotherapy can help people with advanced thymus tumors feel better and live longer after surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Proton and Heavy Ion Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06311955 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness and side effects of carbon ion radiotherapy in patients with advanced thymic epithelial tumors that have undergone R2 resection. Participants will receive a total of 72GyE delivered in 18 fractions, combined with a platinum-based chemotherapy regimen for at least four cycles. The primary focus is on progression-free survival and toxicity, while secondary outcomes include local relapse-free survival, overall survival, and cause-specific survival. The study aims to provide insights into the potential benefits of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with stage II-IV thymic epithelial malignancies who have undergone radical surgery and have visible residual tumors.

Not a fit: Patients with a history of thoracic radiotherapy or those with severe comorbidities affecting organ function may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates and reduce recurrence in patients with advanced thymic tumors.

How similar studies have performed: While carbon ion therapy is a novel approach for thymic tumors, similar studies in other cancers have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Patients with stage II-IV (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiotherapy who had undergone radical surgery (R2 resection, visible residual tumor) and had a definite pathological diagnosis.
* Sign informed consent.
* Between the ages of 18 and 70.
* ECOG general status score of 0-2.
* The expected survival is at least 6 months.
* Adequate organ function: 1). Blood function: absolute neutrophil count (ANC) ≥1.5 x 109/L, platelet count ≥80 x 109/L, hemoglobin ≥9 g/dL 2). Lung function: FEV1\>25%, DLCO\>25% 3). Cardiac function: no serious pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, serious chronic heart disease and other complications that may affect radiotherapy.4). Adequate liver function: total bilirubin \<1.5 times the upper limit of normal value, and AST, ALT\<2 times the upper limit of normal value. 5). Adequate renal function: serum creatinine ≤1.5 times the upper limit of normal or calculated creatinine clearance ≥50 ml /min, and urinary protein \<2+. Patients with a baseline urinary protein level of 2+ or more should have a 24-hour urine collection and evidence of a 24-hour urinary protein level of 1g or less.

Exclusion Criteria:

* Complicated with other malignant tumors that have not been controlled.
* Have large quantity of pleural or pericardial effusion.
* Patient whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the dose constrains of normal tissue or organs.
* Chest radiation therapy or radioactive particle implantation history.
* Cardiac pacemakers or other internal metal prosthesis implants that may be affected by high-energy radiation or may affect the dose distribution to the radiation target area.
* Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
* HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
* A history of mental illness may hinder the completion of treatment.
* With serious comorbidity that may interfere with radiotherapy, including: (a) Acute infectious diseases or acute active phase of chronic infection. b) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. d) Severely impaired immune function. e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. f) Other diseases that may affect particle radiotherapy.
* Other circumstances that the physician considers inappropriate to participate in clinical study.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Proton and Heavy Ion Center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jingfang Mao, PHD — Shanghai Proton and Heavy Ion Center
• Study coordinator: Jing Li

Conditions: Thymic Epithelial Tumor, Radiotherapy Side Effect, Carbon Ion Radiotheray, Heavy Ion Radiotherapy