multiple primary early-stage lung cancer
Conditions
Interventions
Photon radiotherapy group:Photon stereotactic body radiotherapy
Heavy ion radiotherapy group:Carbon ion radiotherapy
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent achieved; Have the ability to comply with the plan; 2. Aged between 18 and 80 years; 3. Pathologically confirmed NSCLC, or clinically diagnosed as NSCLC if no pathological diagnosis was obtained; 4. Patients with peripheral type of T1-2, N0, M0 (American Joint Committee on Cancer staging manual version 8th) multiple primary lung lesions (2 or more), peripherally located type means the primary tumor is located at least 1cm from the chest wall, 2 cm from the esophagus, main bronchial tree, spinal cord, heart, great blood vessels, brachial plexus, and stomach; 5. Deemed medically inoperable or declined surgery; 6. Patients who can not tolerate or reject concurrent chemotherapy; 7. The KPS score no less than 60, and the ECOG general status score is between 0 and 2; 8. The anticipated survival will be >= 12 months; 9. Adequate organs' functions; 10. The position of the lesions can meet the requirements of the design of the radiation field; Patients can hold their positions for more than 30 minutes as the treatment requires. The residual movement of normal tissue and tumor at the pathway of beam must be < = 5mm if breath control technique was used.
Exclusion criteria
Exclusion criteria: 1. Accompanied with other malignant tumors which were not well controlled; 2. The side effects of previous treatment have not recovered; 3. Have a history of thoracic radiation including thoracic radiotherapy, or radioactive particle implantation; 4. Patient with a non-peripherally located pulmonary lesion; 5. The radiotherapy plan fails to meet the minimum dose coverage and dose volume limitation requirements of target area, or the radiation dose limitation of normal organs; 6. Cardiac pacemakers or other metal prostheses that may be interfered with normal functions by high-energy rays or may affect the dose in the radiation target area; 7. During pregnancy (confirmed by serum or urine ß-HCG test) or lactation; 8. Drug or alcohol dependence; 9. There are serious complications that may affect the conduct of radiotherapy, including: (1) Acute infectious diseases; Or acute active exacerbation of chronic infectious diseases; (2) Unstable angina, congestive heart failure, myocardial infarction requiring hospitalization in the past 6 months; (3) Exacerbations of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization; (4) Severely impaired immune function; (5) Hypersensitivity to radiation with ataxia telangiectasia; (6) HIV positive, including a history of antiretroviral therapy; Chronic hepatitis B virus replication period; Hepatitis C active period; Syphilis active stage; (7) HBV positive, hepatitis virus replication stage, need to receive antiviral treatment, but can not receive antiviral treatment because of the accompanying disease; (8) Have a history of mental illness may hinder the completion of treatment; (9) Other diseases that may affect particle therapy; 10. Unable to understand the purpose of treatment or unwilling/unable to sign informed consent; 11. No capacity for civil conduct or limited capacity for civil conduct 12. Doctors think that carbon ion radiotherapy will not benefit the patient; Other situations that physicians do not think it is appropriate to participate in this clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival rate;Overall survival rate;cancer-specific survival rate; | — |
Countries
China
Contacts
Public ContactWu Kai Liang
Shanghai Proton and Heavy Ion Center
Outcome results
None listed