non-small cell lung cancer
Conditions
Interventions
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) Between the ages of 18 and 80; 2) ECOG general status score of 0-2 (at least can walk around freely and take care of themselves, can get up and move at least half the time during the day); 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 central type defined in this study (lung lesions within 2cm from the main bronchial tree, brachial plexus, esophagus, stomach and spinal cord, or within 1cm from mediastinal pleura and pericardium); 5) The operation cannot be performed for medical reasons, or the patient refuses the operation; 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; Cardiac function Class II or lower (according to the New York College of Cardiology Cardiac Function Class (NYHA); 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.
Exclusion criteria
Exclusion criteria: 1) Multiple primary tumors; 2) Patients fail to comply with the treatment plan; 3) Patients with squamous cell carcinoma had received bevacizumab before radiotherapy; 4) Complicated with other malignant tumors that have not been controlled; 5) Patients whose particle radiotherapy plan cannot meet the minimum target dose coverage and dose volume limitation requirements, or cannot meet the radiation dose limitation of normal organs; 6) Chest radiation therapy or radioactive particle implantation history; (7) 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; 8) Pregnancy (confirmed by serum or urine ß-HCG test) or lactation period; 9) HIV positive; Hepatitis virus replication phase, need to receive antiviral therapy, but because of concomitant disease cannot receive antiviral therapy; Active stage of syphilis; 10) A history of mental illness may hinder the completion of treatment; 11) with serious comorbidities 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 therapy; 12) Other circumstances that the physician considers inappropriate to participate in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| local control rate;overall survival rate;toxicity; | — |
Countries
China
Contacts
Public ContactJingfang Mao, Kai-liang Wu, Jian Chen
Shanghai Proton and Heavy Ion Center
Outcome results
None listed