Single High-dose Brachytherapy for Giant Osteosarcoma Masses

Shanghai Jiao Tong University

Status and phase: Not yet enrolling; Phase 2

Conditions: Osteosarcoma

Treatments: Radiation: brachytherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06524778

CSH06R102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

brachytherapy

Experimental group

Description:

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.

Treatment:

Radiation: brachytherapy