The Clinical Study of Post-operative Proton Radiotherapy for Thymus Tumor

Launched by JIAN CHEN · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a specific type of radiation therapy called proton radiotherapy on patients who have had surgery for a thymus tumor. The trial aims to see how well this treatment works in preventing the cancer from coming back and to understand any side effects it may cause. Participants will be closely monitored to see how long they remain free of disease progression and how they respond overall to the treatment.

To be eligible for this trial, participants should be between 18 and 70 years old and have had surgery for a stage II-III thymus tumor. They should have either no remaining cancer cells (R0) or a small number of remaining cancer cells (R1) after surgery. Additionally, they need to have good overall health, with functioning organs, and not have certain serious health issues that could complicate treatment. Those who join the study can expect regular check-ups and support throughout the process. It’s important for potential participants to understand that this is a research study, so they will be helping to gather valuable information that could benefit future patients with similar conditions.

Gender

ALL

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.