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 (modified Bhattacharyya staging) adenoid cystic carcinoma without distant metastasis underwent radical surgery with R1 (microscopic residual) or R0 (microscopic residual) resection but with a margin less than 5mm from the tumor; Had not received chest radiotherapy before coming to our hospital; 2) Sign the informed consent; 3) Between the ages of 18 and 80; 4) Ability to comply with the protocol; 5) ECOG 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 more than or equal to 6 months; 7) Adequate organ function: a) Blood function: absolute neutrophil count (ANC) =4.0 x 109/L, platelet count =100 x 109/L, hemoglobin =11 g/dL b) Lung function: FEV1>40%, or DLCO>40% c) 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); d) Adequate liver function: total bilirubin <1.5 times the upper limit of normal value, AST and ALT<2 times the upper limit of normal value; e) Adequate renal function: serum creatinine =1.5 times the upper limit of normal or calculated creatinine clearance =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 bed 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; With the use of respiratory control technology, the range of residual movement of tumor bed and normal tissue on the beam direction caused by respiratory movement 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: (a) Acute infectious diseases; Or acute active phase of chronic infection; (b) Unstable angina pectoris, congestive heart failure, myocardial infarction requiring hospitalization in the past 6 months; (c) Exacerbations of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization; (d) Severely impaired immune function; (e) Diseases with excessive sensitivity to radiation such as ataxia telangiectasia; (f) 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 |
|---|---|
| progression-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| local control 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