Sarcoma
Conditions
Interventions
Sponsors
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 14 to 80 years old; 2.Patients with locally advanced osteosarcoma (defined as inoperable patients: those assessed as inoperable by two senior orthopedic oncology surgeons); 3.Clinical and imaging examinations confirmed the absence of distant metastasis; 4.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <= 2; 5.Sufficient major organ function; 6.Baseline Assessment: No adverse reactions of grade 2 or higher according to CTCAE 5.0; 7.Able to complete the questionnaire independently or with assistance, and capable of providing written informed consent.
Exclusion criteria
Exclusion criteria: 1. Osteosarcoma not confirmed by pathology; 2. The treatment area has previously received two or more rounds of radiation therapy, or less than 6 months have passed since the last radiation therapy; 3. Dose limits for organs at risk cannot meet the preset safe dose constraints; 4. Presence of metal implants within the irradiation field or along the irradiation path that may affect the dose to the radiation target; 5. Pregnancy (confirmed by serum or urine ß-HCG test) or breastfeeding; 6. Poor overall health (KPS 2); 7. Presence of severe diseases or factors that may affect the ability to carry out radiotherapy, including: (1) Unstable angina, congestive heart failure, or myocardial infarction requiring hospitalization within the past 6 months; (2) Acute bacterial or systemic fungal infection; (3) Exacerbation of chronic obstructive pulmonary disease or other respiratory diseases requiring hospitalization; (4) Immunocompromised patients; (5) Drug abuse or alcohol dependence; (6) History of psychiatric illness that may interfere with completing treatment; (7) Connective tissue diseases, such as active scleroderma or lupus, which are contraindications for radiotherapy; (8) HIV positive (including those who have received antiretroviral therapy), active hepatitis C, active syphilis; (9) Other diseases or factors that may affect particle therapy; 8. Unable to understand the purpose of treatment or unwilling to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PD-L1 expression levels and immune cell infiltration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival ;Local control rate;Progression free surival; | — |
Countries
China
Contacts
Public ContactQing Zhang
The Clinical Technology Research And Development Center of Shanghai Proton and Heavy Ion Center
Outcome results
None listed