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Not yet recruiting NCT06524778

Single High-dose Brachytherapy for Giant Osteosarcoma Masses

Phase II Interventional Osteosarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: brachytherapy.
Who it may be relevant to
Registry conditions: Osteosarcoma. Basic parameters: 12 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • progression-free survival [Time frame: 6 months]
Secondary outcome measures (4)
  • progression-free survival [Time frame: 12 months]
  • progression-free survival [Time frame: 12 months]
  • OS [Time frame: 12 months]
  • Adverse reactions related to radiotherapy [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06524778 · CSH06R102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗