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Single fraction of proton stereotactic body radiotherapy (SBRT) versus multiple fraction of photon SBRT for bone metastatic patients

Single fraction of proton stereotactic body radiotherapy (SBRT) versus multiple fraction of photon SBRT for bone metastatic patients

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220615009
Enrollment
136
Registered
2022-06-15
Start date
2022-08-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

bone metastatic patients bone metastases bone metastatic pain cancer patients

Interventions

using photon for stereotactic body radiotherapy for bone metastatic site,using proton for stereotactic body radiotherapy for bone metastatic site
photon SBRT,proton SBRT

Sponsors

Radiation oncology division, Radiology Department, KCMH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with a pathologic diagnosis of malignancy 2.Aged older than 18 years old 3.Patients with any radiographic evidence of bone metastases, including plain x-ray, bone scan, CT scan , MRI scan or PET scan 4.Patients with spine and non-spine lesions 5.With pain or dysathesia ( Pain score of at least 2 on the scale) 6.Patients with a life expectancy of more than 3 months 7.Patients with solitary or oligometastatic or bone- only metastatic disease 8.Patients who are able to complete NPRS scores and the questionnaire of Quality of life 9.Patients with no more than 3 separate radiation treatment fields concurrently 10.Patients with surgery for osseous metastases allowed 11.Patients with gross residual disease or high risk for recurrence after surgery 12.Patients with prior conventional beam radiation therapy to the treatment site ( more than 90 days after radiation) 13.Patients with spinal cord compression after decompressive surgery

Exclusion criteria

Exclusion criteria: - Patients with radiosensitive tumor such as malignant melanoma - Patients with a pathologic fracture to the treatment site who needs surgery (spinal instability or neurologic deficit resulting from bony fragments) - Patients with spinal canal compromise >25% - Patients with tumor location within 5 mm of spinal cord or caudal equina - Patients who cannot perform spinal MRI with any reasons such as pacemaker - Patients with chemotherapy within 30 days before SBRT - Patients who have systemic radionuclide delivery within 30 days before SBRT - Patients who have previous SBRT

Design outcomes

Primary

MeasureTime frame
pain score 3 months 11 point pain score

Secondary

MeasureTime frame
toxicity 3 months CTCAE version 5

Countries

Thailand

Contacts

Public Contactkitwadee Saksornchai

Faculty of Medicine, Chulalongkorn University

kitwadee.s@chula.ac.th6641655595

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026