NCT06524778

Single High-dose Brachytherapy for Giant Osteosarcoma Masses

The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
RADIATION	brachytherapy	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.

Timeline

• Start date: 2024-08-30
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-07-29
• Last updated: 2024-08-07