Clinical trial NCT06524778: Single High-dose Brachytherapy for Giant Osteosarcoma Masses
Official title: The Therapeutic Effect of Single High-dose Brachytherapy for Locally Inoperable and Metastatic Giant Osteosarcoma Masses
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Osteosarcoma
Keywords: brachytherapy
high-dose
osteosarcoma
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single dose high-dose （10Gy）implantable brachytherapy
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: progression-free survival
timeFrame: 6 months
Secondary outcomes:
measure: progression-free survival
timeFrame: 12 months
measure: progression-free survival
timeFrame: 12 months
measure: OS
timeFrame: 12 months
measure: Adverse reactions related to radiotherapy
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: