tracheobronchial adenoid cystic carcinoma
Conditions
Interventions
Sponsors
Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed stage I to IV (Bhattacharyya modified staging ) adenoid cystic carcinoma without distant metastasis had radiographically evaluable lesions. Had no chest radiotherapy history; 2. Sign the informed consent; 3. Between the ages of 18 and 80; 4. Ability to comply with the protocal; 5. ECOG general status score is 0-2 (at least can walk around freely and take care of themselves, can get up and move at least half of the time during the day); 6. The estimated survival time is larger than or equal to 6 months; 7. Adequate organ function: (1) Blood function: absolute neutrophil count (ANC) >=4.0 x 10^9/L, platelet count >=100 x 10^9/L, hemoglobin >=11 g/dL (2) Lung function: FEV1>40%, or DLCO>40% (3) Cardiac function: no complications such as severe pulmonary hypertension, cardiovascular and cerebrovascular diseases, peripheral vascular diseases, or serious chronic heart disease 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 =50mL/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; 8. The location of the tumor should meet the requirements of the treatment planning; Patients can lie supine or prone for more than 30 minutes in the position required for treatment; After the use of respiratory control techniques such as active respiratory control or respiratory gating, the movement amplitude of the tumor caused by residual respiratory movement and the normal tissue on the beam direction path must be <=5mm.
Exclusion criteria
Exclusion criteria: 1. No pathological confirmation; 2. Suffering from or complicated with other malignant tumors that have not been controlled; 3. Distant metastasis; 4. Chest radiotherapy history; 5. There are metal prosthesis implants in the chest that affect the distribution of particle radiation dose, including metal tracheal stent, etc.; 6. The particle radiotherapy field cannot cover all lesions; 7. Poor liver, kidney and bone marrow function, which does not meet the treatment requirements; 8. Not recovered from he side effects of previous treatment; 9. 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; 10. If a pacemaker is implanted, the function of the pacemaker may be interfered by high-energy beams, or the pacemaker may affect the dose distribution of particle beams; 11. Physicians determined that particle radiotherapy would not benefit patients; 12. Combined with other diseases or other factors that may affect particle therapy; 13. Pregnancy (confirmed by serum or urine ß-HCG test) or lactation period; 14. Drug abuse or alcohol dependence; 15. HIV positive, including previous antiretroviral treatment; Chronic hepatitis B virus replication phase; Hepatitis C active phase; Active stage of syphilis; 16. HBV positive, hepatitis virus replication phase, need to receive antiviral therapy, but cannot receive antiviral therapy because of complications; 17. A history of mental illness may hinder the completion of treatment; 18. with serious comorbidities that may interfere with the conduct of radiotherapy, including but not limited to: (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 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 therapy; 19. Unable to understand the purpose of treatment or unwilling/unable to sign informed consent; 20. No civil capacity or limited civil capacity. 21. Other circumstances in which the physician considers it inappropriate to participate in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local control rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival rate;tumor specific survival 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