NCT05613452RecruitingPhase 2
Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer
Prospective Phase II Clinical Study of Carbon Ion Beam Stereotactic Radiotherapy for Peripheral Type Early-stage Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 13 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To investigate the efficacy of carbon ion therapy for stage Ia-IIa primary peripheral non-small cell lung cancer (NSCLC). The primary endpoint was progression-free survival (PFS), and the secondary endpoint was local control rate, overall survival (OS) and toxicities.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 43 (estimated)
- First submitted
- 26 Oct 2022
- Start date
- 29 Sept 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Shanghai Proton and Heavy Ion Center
- Diseases
- Lung cancer
- NCT number
- NCT05613452
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 43
- From 29 Sept 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
Other illness
- Complicated with other malignant tumors that have not been controlled.
- 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.
- 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.
Lab values
- Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
Other
- Multiple primary tumors.
- Patient fails to comply with the treatment protocol.
- Other circumstances that the physician considers inappropriate to participate in clinical study.
Who the study is looking for
- Between the ages of 18 and 80.
- ECOG general status score of 0-2 .
- Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition).
- The location of the tumor belongs to the peripheral type defined in this study (2cm and beyond (≥2cm) from the esophagus, main bronchial tree, spinal cord, heart, great blood vessels, brachial plexus and stomach, and 1cm and beyond (≥1cm) from the chest wall).
- 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 the informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Proton and Heavy Ion Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.