UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041948 |
|---|---|
| Receipt number | R000047314 |
| Scientific Title | Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2025/08/21 10:20:21 |
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Basic information
Public title
Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
Acronym
SIB-IM-SBRT for bone metastasis of the spine
Scientific Title
Intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine
Scientific Title:Acronym
SIB-IM-SBRT for bone metastasis of the spine
Region
| Japan |
Condition
Condition
Bone metastasis of the spine
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety regarding intensity-modulated stereotactic body radiotherapy with simultaneous integrated-boost in patients with bone metastasis of the spine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
1-year local control rate
Key secondary outcomes
Acute and late adverse events
Progression free survival
Overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The patients with spinal bone metastases will receive SIB-IM-SBRT with 30 Gy in 5 fractions.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with bone metastasis of the spine
2.Life expectancy of at least 1 year
3.Aged 20<= years
4.ECOG performance status 0-2
5.Written informed consent
Key exclusion criteria
1.Patients who had a previous RT to the treatment area
2.Dose constraints of organs at risk are not observed
3.Patients requiring radiotherapy for oncologic emergencies
4.Cases that the dose distribution can not be evaluated exactly.
5.Patients who have psychosis or psychiatric symptoms that interferes with daily life
6.Patients who are unsuitable for enrolment into the study by the investigator's judgment.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Mitsuyoshi |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Radiation Oncology
Zip code
650-0047
Address
2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
TEL
078-302-4321
mitsu.t@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Mitsuyoshi |
Organization
Kobe City Medical Center General Hospital
Division name
Department of Radiation Oncology
Zip code
650-0047
Address
2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
TEL
078-302-4321
Homepage URL
mitsu.t@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe City Medical Center General Hospital
Address
2-chome, Minami-cho, Minatojima, Chuo-ku, Kobe
Tel
078-302-4321
mitsu.t@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40342586/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40342586/
Number of participants that the trial has enrolled
28
Results
A total of 25 patients (28 vertebral segments) were enrolled. Median follow-up was 26.2 months, with 24 segments in 21 patients followed for >1 year. The 1- and 2-year LC rates were 100% and 95%. Local recurrence occurred in 1 patient at 18 months. The 1- and 2-year OS rates were 92% and 72.8%. Six patients developed VCFs (3 grade 1, 3 grade 2), with 1- and 2-year incidence rates of 3.6% and 15.6%. No radiation myelopathy or other grade >=2 AEs occurred, except 1 case of grade 2 pain.
Results date posted
| 2024 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 03 | Month | 03 | Day |
Baseline Characteristics
A total of 25 patients (28 vertebral segments) were included, consisting of 15 males and 10 females, with a median age of 70 years (range, 43-86). The treated sites were the cervical/thoracic/lumbar/sacral spine in 1/11/10/6 cases, respectively. The primary tumors were breast/prostate/lung/others in 9/8/4/7 patients, respectively.
Participant flow
After enrollment, all patients received the study treatment, followed by scheduled follow-up evaluations. Neurologic and pain assessments, along with MRI, were performed at 2 weeks posttreatment (physical examination only), and subsequently at 3, 6, and 12 months. Thereafter, follow-up evaluations were conducted every 6 months. In addition, systemic radiographic examinations, identical to those performed before treatment, were conducted annually after treatment.
Adverse events
Adverse events were observed in 9 patients. Vertebral compression fractures (VCFs) occurred in 6 segments, with grade 2 (symptomatic) and grade 1 (asymptomatic) events in 3 patients each. The median time to VCF onset was 17.0 months (range, 0.9-29.5 months). The 1-year and 2-year cumulative incidence rates of VCF were 3.6% (95% CI, 0.2-15.7%) and 15.6% (95% CI, 4.7-32.4%), respectively. All VCFs were managed conservatively within a few months after onset. Other radiation-related AEs included grade 2 pain, grade 1 esophagitis, and grade 1 radiculitis in one patient each. No cases of radiation myelopathy, neurologic adverse events, or other grade >=2 toxicities were observed.
Outcome measures
The primary endpoint of this study was the 1-year local control (LC) rate. The secondary endpoint was overall survival (OS).
The median follow-up time was 24.0 months per vertebral segment (range, 3.9-37.2) and 26.2 months per patient (range, 4.8-39.1). A total of 24 vertebral segments in 21 patients were followed for more than 1 year with MRI. Only one patient developed local recurrence, resulting in 1- and 2-year LC rates of 100% and 95.0%, respectively. The 1- and 2-year OS rates were 92.0% and 72.8%, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Report for Advances in Radiation Oncology
Title: Phase 2 Trial of Stereotactic Body Radiation Therapy with Dose Escalation Using Simultaneous Integrated Boost for Spinal Metastases
Management information
Registered date
| 2020 | Year | 09 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047314
