Locally advanced non-small cell lung cancer
Conditions
Interventions
Post-radiotherapy observation group:Carbon ion radiotherapy (77Gy/22 times) combined with platinum-based dual-drug chemotherapy
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. Patients sign the informed consent form; 2. Patients aged between 18 and 80 years old; 3. The pulmonary lesion was diagnosed by cytology or histology; 4. The lesion is evaluated as unresectable tumor by thoracic surgeon, or the patient refuses surgery, or the patient is unable to tolerate surgery due to medical contraindications; 5. Primary non-small cell lung cancer with distant metastasis excluded by imaging, and stage including local huge mass (T3-4N0M0); or the primary tumor (T1-4N1-3M0) associated with ipsilateral peribronchial and/or ipsilateral hilar and intrapulmonary lymph node metastasis, including involvement by direct extension; ipsilateral mediastinal and/or subcarinal lymph node metastases; and the contralateral mediastinal, contralateral hilar, ipsilateral or contralateral scalenus or supraclavicular lymph node metastasis; the distance between the primary lesion and the esophageal lesion was >=1cm; 6. KPS>=70, ECOG 0-1; 7. The expected survival time is greater than or equal to 12 months; 8. Adequate organ function: (1) Complete blood count: absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 80 x 10^9/L, hemoglobin >= 9 g/dL; (2) Cardiac function: no severe pulmonary hypertension, cardio-cerebral vascular disease, peripheral vascular disease, severe chronic heart disease and other complications that may affect the radiotherapy; cardiac function (NYHA classification) is grade <=II; 9. The tumor location needs to meet the requirements of radiation field layout; the patient can lie in supine or prone position for more than 30 minutes in the required positioning for treatment; after respiratory control technology is adopted, the movement amplitude induced by respiratory movement of tumor and normal tissue along the beam projection must be <= 5mm.
Exclusion criteria
Exclusion criteria: 1. Patient's disease has not been pathologically confirmed; 2. Patients complicated with other malignant tumors and not yet controlled; 3. Patient's weight loss of more than 10% of the body weight within 6 months before diagnosis; 4. Patients have not been recovered from the side effects of previous chemotherapy, or have not met with the treatment requirements owing to poor bone marrow function; 5. Patients received thoracic radiotherapy or radioactive seed implantation in the past; 6. Patients fail to meet with the minimum target dose coverage and limitations of dose volume requirements, or cannot meet with the dose constraints of normal organs in the radiotherapy plan designing; 7. Patients with cardiac pacemaker or other metal prosthesis implants that may be interfered of its normal function by high-energy radiation delivery or may affect the dose distribution of the irradiated target area; 8. Patients who will not be benefit from carbon-ion radiotherapy by physician judgement; 9. Drug abuse or alcohol dependence; 10. HIV positive, including previously taking antiretroviral treatment; Chronic hepatitis B virus replication phase; Hepatitis C active phase; Active stage of syphilis; 11. Patients with HBV positive, hepatitis virus replication phase, need to receive antiviral therapy, but cannot because of concomitant diseases; 12. Patients with mental illness that may affect the progression of radiotherapy; 13. Patients with serious comorbidities that may affect the progression of radiotherapy, including: 1) Acute infectious diseases, or acute active phase of chronic infection; 2) Unstable angina pectoris, 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) Ataxia telangiectasia and other diseases which are excessive sensitivity to radiation; 6) Pregnancy (via serum or urine ß-HCG test) or during lactation; 7) Other diseases that may affect carbon ion radiotherapy; 14. Patients are unable to understand the purpose of treatment or unwilling/unable to sign the informed consent form; 15. Having no civil capacity or limited civil capacity; 16. Patients who are considered as inappropriate to participate in clinical research by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival rate of tumor; | — |
Secondary
| Measure | Time frame |
|---|---|
| Locally progression-free survival rate;Tumor-specific survival rate;Overall survival rate; | — |
Countries
China
Contacts
Public ContactMao Jingfang
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Outcome results
None listed