Non-small Cell Lung Cancer
Conditions
Interventions
Post-radiotherapy observation group (including hypoxic and non-hypoxic patients):Carbon ion radiotherapy
Sponsors
The Clinical Technology Research And Development Center of 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 years. 2. Have sufficient physical function as well as mental understanding ability to comply with the program; 3. Primary lung lesions or metastatic lymph nodes (mediastinum, clavicle, etc.) should be confirmed by cytology or histology. The tumor was evaluated by thoracic surgery as unresectable, or the patient refused surgery, or the patient was assessed to be unable to tolerate surgery for medical reasons; 4. After imaging evaluation, distant metastasis was excluded, and the tumor stage was IIIA-IIIC (UICC/AJCC 8th edition staging criteria), and the maximum diameter of the primary lesion was >= 4cm; 5. ECOG general status score of 0-2 . 6. The expected survival is at least 6 months. 7. At least 4 courses of chemotherapy containing platinum may be combined with immunotherapy; 8. Adequate organ function: (1) Blood function: absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/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 = 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. 9. The location of the tumor should be able to meet the requirements of the shooting field layout; Patients can lie on their back or stomach for more than 30 minutes in the position required for treatment; After the use of respiratory control technology, the movement amplitude of the tumor caused by respiratory movement and the normal tissue on the incident path must be less than 5mm.
Exclusion criteria
Exclusion criteria: 1.Have a second primary tumor (skin basal cell carcinoma, cervical carcinoma in situ, thyroid papilloma and have a tumor-free survival of more than 3 years after treatment); 2.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. 3.Chest radiation therapy or radioactive particle implantation history; 4.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; 5.Pregnancy (confirmed by serum or urine ß-HCG test) or lactation period. 6.Abuse drugs or alcohol dependence; 7.HIV positive, including having been on antiretroviral therapy; Chronic hepatitis B virus replication stage; Hepatitis C active phase; Syphilitic stage; 8.HBV positive, hepatitis virus replication phase, need to receive antiviral treatment, but because of concomitant disease can not receive antiviral treatment; 9.A history of mental illness may hinder the completion of treatment. 10.With serious comorbidity that may interfere with radiotherapy, including: (1) Acute infectious diseases or acute active phase of chronic infection. (2) Unstable angina pectoris, congestive heart failure, myocardial infarction that has been hospitalized in the past 6 months. (3) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization. (4) Severely impaired immune function. (5) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia. (6) Other diseases that may affect particle radiotherapy. 11.Contraindications for radiation therapy with connective tissue diseases such as active scleroderma or lupus; 12.Inability to understand the purpose of treatment or unwillingness/inability to sign informed consent; 13.No capacity or limited capacity for civil conduct; 14.Other circumstances that the physician considers inappropriate to participate in clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate;Overall survival rate;toxicity; | — |
Countries
China
Contacts
Public ContactJian Chen
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Outcome results
None listed