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

Phase 2

• Conditions: bone metastatic patients; bone metastases; bone metastatic pain; cancer patients

• Registration Number: TCTR20220615009
• Lead Sponsor: Radiation oncology division, Radiology Department, KCMH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-15
• Study Completion: 2024-07-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 136

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

-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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain score 3 months 11 point pain score

Secondary Outcome Measures

Name	Time	Method
toxicity 3 months CTCAE version 5