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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brachytherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brachytherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 6 months of progression-free survival | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 12 months progression-free survival | 12 months |
| progression-free survival | 12 months of progression-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojing Yang, Dr | Contact | 86-21-2405-8972 | yangxj717@163.com | |
| Jie Fu, Dr | Contact | 86 21 24058973 | fujie74@sjtu.edu.cn |
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No.
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| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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Single dose high-dose (10Gy)implantable brachytherapy
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|
| 12 months |
| OS | 12 months of OS | 12 months |
| Adverse reactions related to radiotherapy | Adverse reactions | 12 months |
| D009369 | Neoplasms |
| D012509 | Sarcoma |