Single High-dose Brachytherapy for Giant Osteosarcoma Masses

ConditionOsteosarcoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-70
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: brachytherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression-free survival

6 months of progression-free survival

Time frame
6 months

Secondary outcomes

1

progression-free survival

12 months progression-free survival

Time frame
12 months
2

progression-free survival

12 months of progression-free survival

Time frame
12 months
3

OS

12 months of OS

Time frame
12 months
4

Adverse reactions related to radiotherapy

Adverse reactions

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: