Thoracic malignancy
Conditions
Interventions
Carbon-ion re-irradiation:Carbon-ion re-irradiation
Sponsors
Shanghai Proton and Heavy Ion Center (SPHIC)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 years old; 2. Obtain cytological or histological diagnosis of the primary/primary lesion, clinically diagnosed as chest tumors, including non-small cell lung cancer, small cell lung cancer, mediastinal malignant tumors (thymic malignant tumors and primary unknown tumors), sarcomas, etc; 3. Previously received chest radiation therapy (>=45Gy), with imaging assessment indicating recurrence after radiation therapy; 4. The interval between the recurrence of the lesion and the end of the previous radiotherapy exceeds 6 months; 5. The recurrent focus is evaluated as an unresectable tumor by thoracic surgery, or the patient refuses surgery, or the patient is evaluated as unable to tolerate surgery due to medical reasons; 6. The KPS score is greater than or equal to 70, and the ECOG general status score is 0-1 levels; 7. 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) Cardiac function: There are no comorbidities such as severe pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, or serious chronic heart disease that may affect the progress of radiotherapy; Cardiac function classification II and below (according to the New York Heart Association Cardiac Function Classification (NYHA); 3) Lung function: FEV1>25%, or DLCO>25%; 8. The location of the tumor needs to meet the requirements for field layout; Patients can lie supine or prone for more than 30 minutes in the position required for treatment; After the use of respiratory control technology, the normal tissue movement amplitude caused by respiratory movement in the tumor and incident pathway must be<=5mm.
Exclusion criteria
Exclusion criteria: 1. Patients complicated with other malignant tumors and not yet controlled; 2. Patients have not been recovered from the side effects of previous radiotherapy (including but not limited to: esophageal/tracheal fistula; grade III and above esophagitis, radiation pneumonitis, radiation pulmonary fibrosis, chest pain, rib fracture, hemoptysis; other side effects with grade IV and above, etc.); 3. Patients have received thoracic brachytherapy in the past (including interstitial brachytherapy, intracavitary radiotherapy, radioactive seed implantation and other treatments that cannot be accurately evaluated of the irradiated dose of normal tissues); 4. 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 carbon-ion re-irradiation plan designing; 5. 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; 6. Patients with serious complications that may affect the progression of radiotherapy; 7. Pregnancy (via serum or urine ß- HCG test) or during lactation; 8. Drug abuse or alcohol dependence; 9. Patients who will not be benefit from carbon-ion re-irradiation by physician judgement 10. Patients are unable to understand the purpose of treatment or unwilling/unable to sign the informed consent form; 11. Patients who are considered as inappropriate to participate in clinical research by physicians.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival rate;Distant metastasis free survival rate; | — |
Countries
China
Contacts
Public ContactJingfang Mao
Shanghai Proton and Heavy Ion Center (SPHIC)
Outcome results
None listed