Spine MetastasesNCT05495399
Post Operative RT for Limited Spine Metastases
A study testing Spondylectomy and SBRT in people with Spine Metastases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spine Metastases
- What is being tested?
- Spondylectomy and SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2022to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
- Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.
- A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
- Patients aged at least 20 years old are eligible.
- Life expectancy of ≥ 6 months.
- ECOG performance status 0-2 (ECOG 3-4 related to cord compression can be enrolled after physician assessment)
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- No prior RT to the index spine level(s)
- Women of childbearing potential must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent.
Who cannot join
- Patients received prior radiotherapy to the index spine level.
- Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
- Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
- Patients who cannot tolerate radiotherapy immobilization.
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
- Uncontrolled active infection requiring intravenous antibiotics at the time of registration
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- Transmural myocardial infarction ≤ 6 months prior to registration.
- Life-threatening uncontrolled clinically significant cardiac arrhythmias.
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
- Uncontrolled psychiatric disorder.
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Wen Chi Yang, +886223123456, claireds23@ntuh.gov.tw
About this study
Official title: Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.
- Conditions
- Spine Metastases
- Being tested
- Spondylectomy, SBRT
- Keywords
- Stereotactic body radiotherapy, Spondylectomy, Separation surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpondylectomyProcedure or surgery
Patient will be randomized to treated by spondylectomy or debulking surgery. Spondylectomy implied total resection of involved spine; while debulking surgery means partial resection of involved spine.
SBRTRadiation
Patient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT.
| Study group | Role | What they receive |
|---|---|---|
| Spondylectomy with Conventional RT | Experimental | Spondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions Receives: Procedure: Spondylectomy |
| Debulking surgery with Conventional RT | Active comparator | Debulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions Receives: Procedure: Spondylectomy; Radiation: SBRT |
| Debulking surgery with SBRT | Experimental | Debulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
Number of patients with locally controlled disease of index spine after intervention
Measured: 12 months post surgery
Secondary outcomes (6)
Overall survival
Survival from treatment to death
Measured: 12 months post surgery
pain control
using numerical pain score to assess pain
Measured: Every 3 months up to 1 year post surgery
Quality of life assessment
EORTC QLQ-C15 PAL
Measured: Every 3 months up to 1 year post surgery
Quality of life assessment
Spine Oncology Study Group Outcomes Questionnaire 2.0 (SOSGOQ 2.0)
Measured: pre surgery and 1 month after surgery
Quality of life assessment
EORTC QLQ-BM22
Measured: Every 3 months up to 1 year post surgery
Treatment related toxicity
Using Common Terminology Criteria for Adverse Events
Measured: Every 3 months up to 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Aug 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine MetastasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495399
- Sponsor's protocol ID
- 202204039RINA
- Status last verified
- Feb 2024
- First submitted
- 4 Aug 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing required by other researchers will be discussed in institution
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery for Limited Spine Metastases Followed by Conventional Radiotherapy or Stereotactic Body Radiation Therapy
- ClinicalTrials.gov ID
- NCT05495399
- Acronym / sponsor ID
- 202204039RINA
- Conditions
- Spine Metastases
- Keywords
- Stereotactic body radiotherapy, Spondylectomy, Separation surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate patients with limited spine metastases treated with total spondylectomy followed by conventional radiotherapy or debulking surgery followed by SBRT or conventional RT. The study primary endpoint is one year local control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spondylectomy with Conventional RT | Experimental | Procedure: SpondylectomySpondylectomy for involved spine level followed by conventional RT 20Gy in 5 fractions |
| Debulking surgery with Conventional RT | Active comparator | Procedure: Spondylectomy, Radiation: SBRTDebulking surgery for involved spine level followed by conventional RT 20Gy in 5 fractions |
| Debulking surgery with SBRT | Experimental | Radiation: SBRTDebulking surgery for involved spine level followed by SBRT 24Gy in 12 fractions |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who had pathologically proved solid cancer, with radiographic evident limited spine metastases indicative and feasible for spondylectomy or debulking surgery.
- Patients with maximum two continuous level of spine metastases need for surgery are eligible. Patients who have other spine metastases but not necessary for surgery are allowed.
- A preoperative gadolinium enhance MRI should be obtained up to 8 weeks before enrollment.
- Patients aged at least 20 years old are eligible.
- Life expectancy of ≥ 6 months.
Key exclusion criteria (12 listed)
- Patients received prior radiotherapy to the index spine level.
- Patients who cannot receive Gadolinium enhanced MRI due to pacemaker or metal implant or who cannot receive contrast enhanced CT scan due to impaired renal function.
- Patients who have hematological cancer or primary spine tumor will be excluded for enrolment.
- Patients who cannot tolerate radiotherapy immobilization.
- Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements, defined as follows:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpondylectomyPatient will be randomized to treated by spondylectomy or debulking surgery. Spondylectomy implied total resection of involved spine; while debulking surgery means partial resection of involved spine. | Procedure or surgery | Debulking surgery with Conventional RT, Spondylectomy with Conventional RT |
| SBRTPatient received debulking surgery will be randomized to receive SBRT or conventional RT. SBRT means high dose per fraction compared to conventional RT. | Radiation | Debulking surgery with Conventional RT, Debulking surgery with SBRT |
Primary outcome
Local control
Time frame: 12 months post surgery
Number of patients with locally controlled disease of index spine after intervention
6 secondary outcomes
Overall survival
Time frame: 12 months post surgery
pain control
Time frame: Every 3 months up to 1 year post surgery
Quality of life assessment
Time frame: Every 3 months up to 1 year post surgery
Quality of life assessment
Time frame: pre surgery and 1 month after surgery
Quality of life assessment
Time frame: Every 3 months up to 1 year post surgery
Treatment related toxicity
Time frame: Every 3 months up to 1 year post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. IPD sharing required by other researchers will be discussed in institution
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spondylectomy and SBRT in people with Spine Metastases, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Chi Yang (+886223123456, claireds23@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: 12 months post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.