Post-operative proton radiotherapy for thymus tumors

Prospective Phase II Clinical Study of R0/R1 Post-operative Proton Radiation Therapy for Thymus Epithelial Malignancies

This study is testing if proton radiotherapy after surgery can help patients with advanced thymus tumors live longer and feel better, while also looking at any side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Proton and Heavy Ion Center (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06311968 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness and side effects of proton radiotherapy administered after surgery for patients with locally advanced thymus epithelial tumors. Patients who have undergone R0 resection will receive a specific dosage of proton irradiation, while those with R1 resection will receive a higher dosage. Additionally, participants will undergo a regimen of platinum-based chemotherapy prior to radiotherapy. The study aims to measure progression-free survival and overall survival rates, along with assessing the associated toxicities.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with stage II-III thymus epithelial malignancies who have undergone radical surgery.

Not a fit: Patients with a history of thoracic radiation therapy or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve survival rates and reduce toxicities for patients with thymus tumors.

How similar studies have performed: Other studies have shown promising results with proton therapy for various cancers, suggesting potential success for this approach in thymus tumors.

Eligibility criteria

Inclusion Criteria:

* Patients with stage II-III (Masaoka-Koga) thymus epithelial malignancies without a history of thoracic radiation therapy, who have undergone radical surgery and have a definite pathological diagnosis, and undergone surgery for R0 (no microscopic residual disease) or R1 (microscopic residual disease) resection, and have indication of postoperative radiation therapy.
* 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.
* 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 Thymus Epithelial Tumor; Proton Radiotherapy; Radiation Toxicity