Osteosarcoma
Conditions
Keywords
brachytherapy, high-dose, osteosarcoma
Brief summary
This study is a prospective, single-arm, phase II, single-center study. Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.
Detailed description
Screening period: Local MRI or CT examination, blood routine and coagulation function test. Selected treatment period: All enrolled patients received one dose of close range interstitial radiotherapy with a radiation dose of 10 Gy. The number of insertion needles depends on the size and location of the tumor. The instrument used for radiotherapy is the Medda high-dose rate brachytherapy machine, and the radiation source is 192 iridium. Record treatment related acute events such as bleeding during the treatment period. Follow up: Follow up with local MRI or CT at 1 month, 3 months, 6 months, and 1 year after the end of radiotherapy treatment to evaluate the treatment effect; Simultaneously follow up with patients for survival and treatment related adverse reactions, such as dermatitis, infections, etc.
Interventions
RADIATIONbrachytherapy
Patients with locally unresectable giant osteosarcoma masses who meet the criteria are enrolled in the experimental group, and all patients receive a single dose of 10Gy of implantable brachytherapy. Record treatment-related acute events during and after treatment. Follow up on survival and local control after treatment ends, marking the end of the trial treatment.
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single dose high-dose （10Gy）implantable brachytherapy
Eligibility
Sex/Gender
ALL
Age
12 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pathological diagnosis of osteosarcoma; 2. Age range 12-70 years old; 3. The primary or metastatic lesion cannot be surgically removed based on clinical evaluation, and treatment with internal medicine multi line chemotherapy, targeted therapy, immunotherapy, etc. is ineffective; 4. ECOG physical fitness status is 0-1 points; 5. According to RECIST version 1.1 standard, there must be at least one evaluable target lesion with a mass length diameter greater than 5cm; 6. Sign a written informed consent form before conducting any experimental activities; 7. Researchers determine that they are able to comply with the research protocol; 8. Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures.
Exclusion criteria
1. Local mass previously received radiation therapy; 2. Major surgery ≤ 4 weeks before enrollment; 3. Previous or concurrent malignant tumors (excluding malignant tumors that have been cured and have a cancer free survival of more than 5 years, such as basal cell carcinoma of the skin and papillary thyroid carcinoma); 4. Pregnant or lactating women; 5. Active pulmonary tuberculosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 6 months | 6 months of progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 12 months | 12 months progression-free survival |
| OS | 12 months | 12 months of OS |
| Adverse reactions related to radiotherapy | 12 months | Adverse reactions |
Contacts
Primary ContactXiaojing Yang, Dr
Backup ContactJie Fu, Dr
Outcome results
None listed