Single High-dose Brachytherapy for Giant Osteosarcoma Masses
- Sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Study ID
- NCT06524778
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Osteosarcoma
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- brachytherapy — RADIATIONPatients 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.
Study Details
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.
Key Dates
- First listed
- Jul 29, 2024
- Start date
- Aug 30, 2024
- Status verified
- Aug 2024
- Primary completion
- Jun 30, 2027
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 16 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: brachytherapyPatients 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.
Primary Outcome Measure
progression-free survival [ Time Frame: 6 months ]
Central Contacts
- Xiaojing Yang, Dr86-21-2405-8972
- Jie Fu, Dr86 21 24058973
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