Carbon ion radiotherapy for elderly patients with advanced lung cancer
A Prospective Phase II Clinical Study of Carbon Ion Radiotherapy for Locally Advanced Non-small Cell Lung Cancer in the Older Adult
This study is testing if carbon ion radiotherapy can help older patients with advanced lung cancer feel better and live longer while looking at any side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 29 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Shanghai Proton and Heavy Ion Center Academic / other |
| Drugs / interventions | bevacizumab, radiation, chemotherapy, immunotherapy, Pembrolizumab |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06311981 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects and toxicity of carbon ion radiotherapy in patients over 75 years old with locally advanced non-small cell lung cancer. Participants will receive 70Gy of carbon ion radiotherapy in 20 fractions, and those with specific genetic mutations may also receive targeted therapies. For patients not suitable for targeted therapy, chemotherapy will be administered sequentially with radiotherapy. The study will monitor progression-free survival, toxicity, local control rates, and overall survival through regular follow-ups.
Who should consider this trial
Good fit: Ideal candidates are patients over 75 years old with medically inoperable, locally advanced non-small cell lung cancer.
Not a fit: Patients with early-stage lung cancer or those who are not medically fit for radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve survival rates and quality of life for elderly patients with advanced lung cancer.
How similar studies have performed: Other studies have shown promising results with carbon ion radiotherapy in various cancers, suggesting potential success in this approach for lung cancer.
Eligibility criteria
Show full inclusion / exclusion 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.
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
- Email: jing.li@sphic.org.cn
- Phone: 86-21-38296678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.