Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis

Phase I/II trial of percutaneous vertebroplasty combined with radiotherapy for vertebral metastasis - Phase I/II trial of PVP+RT for vertebral metastasis

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000031321

Enrollment

Registered

2018-02-15

Start date

2018-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

vertebral metastasis

Interventions

Percutaneous vertebroplasty Radiation therapy 30Gy/3fr/10times, 20Gy/4fr/5times, or 8Gy/1fr/1time

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The terget lesion was diagnosed as vertebral metastasis. 2)The terget lesion was thoracic or lumber vertebrae. 3)The number of terget lesions was within 3.4)Bilsky Grade >= 1b 5)Patient has pain from the lesions under analgesic. 6)SINS >= 7 or SINS <= 6 and meet the below. a)Lytic lesions with > 1/3 vertebral body involved b)Lytic lesions with pain in mortion c)Lesions with vertebral collapse 7)The period of prognosis > 3 month

Exclusion criteria

Exclusion criteria: 1)Patients can not maintain the position needed for treatment 2)Target lesions is cervical vertebrae or sacrum 3)The number of terget lesions was more than 4. 4)Bilsky Grade >= 1c 5)History of radiation therapy or surgery for target lesions 6)Bleeding tendency (Platelet counts <= 50,000 or PT-INR > 1.5) 7)Spondylitis or discitis 8)History of major drug allergy

Design outcomes

Primary

Measure	Time frame
To evaluate short-time safety of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events	—

Secondary

Measure	Time frame
To evaluate safety and efficacy of percutaneous vertebroplasty combined with radiation therapy for vertebral metastasis with symptomatic skeletal events	—

Countries

Japan

Contacts

Public ContactTakuya Okada

Kobe University Hospital Department of Diagnostic and Interventional Radiology

okataku@med.kobe-u.ac.jp078-382-6104

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026