Clinical Study of Postoperative Carbon Ion Radiotherapy for Thymus Tumor With Residual Tumor

Launched by JIAN CHEN · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a type of treatment called carbon ion radiotherapy for patients with a specific type of tumor called thymic epithelial tumors. These tumors are located in the thymus gland and can sometimes leave behind residual cancer after surgery. The main goal of the trial is to find out how well this treatment works in preventing the cancer from getting worse and to understand the side effects that might occur. They will also look at how long patients can live without the cancer coming back.

To be eligible for this trial, participants need to be between 18 and 70 years old and have had surgery for their thymic tumor, which still has some visible cancer left. Patients should also be in fairly good health overall, meaning they can perform daily activities and have stable organ functions. If you or a family member are considering participating, it's important to know that the trial is currently recruiting patients and that you will need to sign a consent form to join. Throughout the study, participants can expect close monitoring to track their health and the effects of the treatment.

Gender

ALL

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.