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NCT Number: NCT06524778

Single High-dose Brachytherapy for Giant Osteosarcoma Masses

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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Key information

Age range

12 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. progression-free survival

    Time frame: 6 months

    6 months of progression-free survival

Secondary outcomes

  1. progression-free survival

    Time frame: 12 months

    12 months progression-free survival

  2. progression-free survival

    Time frame: 12 months

    12 months of progression-free survival

  3. OS

    Time frame: 12 months

    12 months of OS

  4. Adverse reactions related to radiotherapy

    Time frame: 12 months

    Adverse reactions

Study contacts

Contact information is provided by the study sponsor or research team.

Jie Fu, Dr

CONTACT

[email protected]

86 21 24058973

Xiaojing Yang, Dr

CONTACT

[email protected]

86-21-2405-8972

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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