Status:
NOT_YET_RECRUITING
Single High-dose Brachytherapy for Giant Osteosarcoma Masses
Lead Sponsor:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Conditions:
Osteosarcoma
Eligibility:
All Genders
12-70 years
Phase:
PHASE2
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 a...
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...
Eligibility Criteria
Inclusion
- Pathological diagnosis of osteosarcoma;
- Age range 12-70 years old;
- 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;
- ECOG physical fitness status is 0-1 points;
- According to RECIST version 1.1 standard, there must be at least one evaluable target lesion with a mass length diameter greater than 5cm;
- Sign a written informed consent form before conducting any experimental activities;
- Researchers determine that they are able to comply with the research protocol;
- Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures.
Exclusion
- Local mass previously received radiation therapy;
- Major surgery ≤ 4 weeks before enrollment;
- 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);
- Pregnant or lactating women;
- Active pulmonary tuberculosis.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06524778
Start Date
August 30 2024
End Date
June 30 2027
Last Update
August 7 2024
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