RecruitingNon-small Cell Lung Cancer
Carbon Ion Therapy for Peripheral Non-small Cell Lung Cancer
Eligible age
18–80 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Shanghai Proton and Heavy Ion Center
You may qualify if…
- ✓ 1. Between the ages of 18 and 80.
- ✓ 2. ECOG general status score of 0-2 .
- ✓ 3. Primary non-small cell lung cancer (NSCLC) confirmed by histology or cytological pathology, T1-2N0M0, stage Ia-IIa (AJCC/UICC 8th edition).
- ✓ 4. 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).
- ✓ 5. Medically inoperable, or patient refuses surgery.
- ✓ 6. 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.
- ✓ 7. Sign the informed consent.
You may not qualify if…
- ✕ 1. Multiple primary tumors.
- ✕ 2. Patient fails to comply with the treatment protocol.
- ✕ 3. Complicated with other malignant tumors that have not been controlled.
- ✕ 4. 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.
- ✕ 5. Chest radiation therapy or radioactive particle implantation history.
- ✕ 6. 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.
- ✕ 7. Pregnancy (confirmed by serum or urine β-HCG test) or lactation period.
- ✕ 8. HIV positive. Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy. Active stage of syphilis.
Source: ClinicalTrials.gov · NCT05613452 · last updated 2025-06-13