Carbon Ion Radiotherapy for Locally Advanced Lung Cancer in Elderly Patients

Launched by JIAN CHEN · Mar 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of carbon ion radiotherapy, a type of advanced radiation treatment, on elderly patients aged 75 and older who have locally advanced non-small cell lung cancer (NSCLC). The goal is to see how well this treatment works and what side effects it might cause. To be eligible for the trial, patients must be over 75, have a confirmed diagnosis of NSCLC that cannot be surgically removed, and meet certain health criteria, such as having good blood, lung, heart, liver, and kidney function.

Participants in the trial will receive carbon ion radiotherapy and may also receive other treatments like chemotherapy or immunotherapy, depending on their specific situation. Before joining, patients will need to provide informed consent, meaning they agree to take part in the study after understanding the details. This trial is currently recruiting participants, so it’s a great opportunity for eligible patients to access a potentially beneficial treatment option while contributing to important research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Older than 75 years old.
• • ECOG general status score of 0-2.
• • Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-4N1-3M0, stage IIb-IIIc (AJCC/UICC 8th edition).
• • Medically inoperable, or patient refuses surgery.
• • 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.
• • Sign informed consent.
• Exclusion Criteria:
• • Patient with squamous cell carcinoma was treated with bevacizumab before carbon ion radiotherapy.
• • Complicated with other malignant tumors that have not been controlled.
• • 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.