Single High-dose Brachytherapy for Giant Osteosarcoma Masses

NCT06524778 — Phase 2, Not yet recruiting, 16 participants, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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

Registry	NCT06524778
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	16 (Estimated)
Sponsor	Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)
Conditions	Osteosarcoma
Interventions	brachytherapy (Radiation)
Dates	start 2024-08-30 (estimated), primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2024-07-29, last updated 2024-08-07

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
brachytherapy	Experimental	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.

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.

+Outcome measures

Primary outcomes

progression-free survival [6 months]: 6 months of progression-free survival

Secondary outcomes

progression-free survival [12 months]: 12 months progression-free survival
progression-free survival [12 months]: 12 months of progression-free survival
OS [12 months]: 12 months of OS
Adverse reactions related to radiotherapy [12 months]: Adverse reactions

+Eligibility

Sex: All, ages: 12 Years to 70 Years

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.