Secondary Malignant Neoplasm of SpineNCT02608866
Single Versus Multiple Fractionated SSRS for Spinal Metastases
A study testing SF-SSRS and MF-SSRS in people with Secondary Malignant Neoplasm of Spine, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators proposed this randomized study to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate their toxicity profiles. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Secondary Malignant Neoplasm of Spine
- What is being tested?
- SF-SSRS and MF-SSRS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Nov 2015to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- To be eligible for inclusion, patients must fulfill the following criteria:
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum three separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Patients with metastatic epidural spinal cord compression (≥ grade 2) at the index spine(s) who will not be treated with spine surgery after evaluation by neurosurgeon or orthopedic doctor
Show all 28Show fewer
- Age ≥ 20 years
- Karnofsky performance status (KPS) ≥ 60%.
- Life expectancy of ≥ 4 month.
- Women of childbearing potential and male participants must practice adequate contraception
- Patients must be able to comply with the study protocol and follow-up schedules and provide study-specific informed consent
- Exclusion criteria Patients fulfill any of the following criteria will be excluded from this trial
- Prior radiotherapy to the index spine(s)
- Serum creatinine > 2.0 mg/dL within 90 days prior registration
- Contraindication to MRI such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with leptomeningeal involvement or intramedullary metastasis
- Inability to tolerate treatment procedure
- Bony retropulsion causing neurologic abnormality
- 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
- Transmural myocardial infarction ≤ 6 months prior to registration
- Unstable angina or congestive heart failure requiring hospitalization ≤ 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
- Will receive any other investigational agent or chemotherapy and/or target therapies during treatment
- Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases
The investigators proposed this randomized study to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate their toxicity profiles. The investigators' analysis will provide robust data as well as predictive factors regarding the outcome after SSRS.
Read the detailed description
Although conventionally fractionated radiation therapy has been utilized for decades, the rates of complete pain relief and local control for complex tumors are sub-optimal. The management of patients with spine metastasis has undergone a great deal of change in the past 5 years. Improvements in neuroimaging, computer-assisted treatment planning, and radiation therapy techniques have led to the development of extracranial radiosurgery.
SSRS is rapidly being adopted in the clinic as preliminary applications of SSRS appears promising. However, the role of SSRS remains in its infancy and lacked high-quality evidence about the treatment schedule and lacked a solid understanding of the adverse events. The Radiation Therapy Oncology Group (RTOG) 0631 phase 2/3 study was initiated to determine whether a more intensive radiation dose delivered by image guided 16-Gy dose single fraction SRS could improve pain control and quality of life as compared with conventional external-beam radiotherapy in patients with localized spine metastases . While other group used treatment schedule in a total dose of 27-30 Gy in three fractions.
Serious adverse events such as vertebral compression fracture (VCF) is a fairly low-risk adverse event after conventional radiotherapy, nevertheless, the crude risk estimates for VCF after spinal stereotactic body radiation therapy is relative more frequent. Previous reports has raised the caution about the given dose and predictive factors, however; whether these two most widely used SSRS schedule (ie. single fraction versus three fractions) provide equivalent pain control and minimal side effects remained to be answered.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3 or higher adverse events between the two most widely adopted scheme. Thus, the investigators proposed the randomized study to determine the feasibility of delivering a single 16-Gy SRS dose versus 3 fractions 24-Gy SRS dose and tried to evaluate the toxicity profile and gain robust data as well as predictive factors regarding the risk of complications after SSRS, including VCF. The investigators will incorporate the recently developed and reported reliable Spinal Instability Neoplastic Scoring (SINS) system and well-designed patient reported outcome measures (PROMs) into the protocol to predict the adverse event and quality of life of each participant. The researchers also tried to investigate the possible associations of the potential bone biomarkers for the risk assessment of SSRS-related adverse bone events.
Since the patients were randomized for treatment arms, the effectiveness of SSRS treatment scheme and adverse profile can be investigated more properly in the present study.
- Conditions
- Secondary Malignant Neoplasm of Spine
- Being tested
- SF-SSRS, MF-SSRS
- Keywords
- stereotactic ablative radiotherapy, spine metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF-SSRSRadiation
Spine stereotactic radiosurgery/ablative radiotherapy (SSRS) with 16 Gy in single fraction to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).
MF-SSRSRadiation
SSRS with 24 Gy in three fractions to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Treatment should be given on every other day. Treatment on the consecutive days to the same target volume is not allowed.
| Study group | Role | What they receive |
|---|---|---|
| SF-SSRS | Experimental | Single-Fraction (SF) Stereotactic Spine Radiosurgery Receives: Radiation: SF-SSRS |
| MF-SSRS | Experimental | Multiple-Fraction (MF) Stereotactic Spine Radiosurgery Receives: Radiation: MF-SSRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common Toxicity Criteria for Adverse Events version 4 Grade 3 or higher adverse events related to spine radiosurgery
The rate of 4-month Common Toxicity Criteria for Adverse Events version 4 grade 3 or higher adverse events definitely, probably or possibly related to treatment
Measured: 16 weeks after SSRS
Secondary outcomes (8)
The pain response rate at the treated index site(s) at 4 months by the numerical rating pain scale
Measured: 16 weeks after Stereotactic Spine Radiosurgery
Health-related quality of life for palliative cancer care patients
European Organization for Research and Treatment of Cancer Quality of Life-Core 30 questionnaire module and Quality of Life questionnaire for palliation
Measured: 1-, 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery
Local control rate at the treated index site(s)
Measured: From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 60 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Measured: Within 90 days after Stereotactic Spine Radiosurgery
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Measured: From 90 days after Stereotactic Spine Radiosurgery until the date of death from any cause, up to 60 months
Changes of spinal cord function by Frankel's classification grading system for spine injury at 4 months
Measured: 16 weeks after Stereotactic Spine Radiosurgery
Tumor-related spinal instability by the Spinal Instability Neoplastic Score (SINS) at 4 months.
Measured: 16 weeks after Stereotactic Spine Radiosurgery
Osseous changes of the treated index site(s) on CT scan within 12 months
Measured: 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start16 Nov 2015
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Malignant Neoplasm of SpineStudies 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608866
- Sponsor's protocol ID
- 201509057RIND
- Status last verified
- Mar 2019
- First submitted
- 13 Nov 2015
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases
- ClinicalTrials.gov ID
- NCT02608866
- Acronym / sponsor ID
- 201509057RIND
- Conditions
- Secondary Malignant Neoplasm of Spine
- Keywords
- stereotactic ablative radiotherapy, spine metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Nov 2015 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- 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.
The investigators proposed this randomized study to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate their toxicity profiles. The investigators' analysis will provide robust data as well as predictive factors regarding the outcome after SSRS.
Detailed description
Although conventionally fractionated radiation therapy has been utilized for decades, the rates of complete pain relief and local control for complex tumors are sub-optimal. The management of patients with spine metastasis has undergone a great deal of change in the past 5 years. Improvements in neuroimaging, computer-assisted treatment planning, and radiation therapy techniques have led to the development of extracranial radiosurgery.
SSRS is rapidly being adopted in the clinic as preliminary applications of SSRS appears promising. However, the role of SSRS remains in its infancy and lacked high-quality evidence about the treatment schedule and lacked a solid understanding of the adverse events. The Radiation Therapy Oncology Group (RTOG) 0631 phase 2/3 study was initiated to determine whether a more intensive radiation dose delivered by image guided 16-Gy dose single fraction SRS could improve pain control and quality of life as compared with conventional external-beam radiotherapy in patients with localized spine metastases . While other group used treatment schedule in a total dose of 27-30 Gy in three fractions.
Serious adverse events such as vertebral compression fracture (VCF) is a fairly low-risk adverse event after conventional radiotherapy, nevertheless, the crude risk estimates for VCF after spinal stereotactic body radiation therapy is relative more frequent. Previous reports has raised the caution about the given dose and predictive factors, however; whether these two most widely used SSRS schedule (ie. single fraction versus three fractions) provide equivalent pain control and minimal side effects remained to be answered.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3 or higher adverse events between the two most widely adopted scheme. Thus, the investigators proposed the randomized study to determine the feasibility of delivering a single 16-Gy SRS dose versus 3 fractions 24-Gy SRS dose and tried to evaluate the toxicity profile and gain robust data as well as predictive factors regarding the risk of complications after SSRS, including VCF. The investigators will incorporate the recently developed and reported reliable Spinal Instability Neoplastic Scoring (SINS) system and well-designed patient reported outcome measures (PROMs) into the protocol to predict the adverse event and quality of life of each participant. The researchers also tried to investigate the possible associations of the potential bone biomarkers for the risk assessment of SSRS-related adverse bone events.
Since the patients were randomized for treatment arms, the effectiveness of SSRS treatment scheme and adverse profile can be investigated more properly in the present study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SF-SSRS | Experimental | Radiation: SF-SSRSSingle-Fraction (SF) Stereotactic Spine Radiosurgery |
| MF-SSRS | Experimental | Radiation: MF-SSRSMultiple-Fraction (MF) Stereotactic Spine Radiosurgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum three separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Patients with metastatic epidural spinal cord compression (≥ grade 2) at the index spine(s) who will not be treated with spine surgery after evaluation by neurosurgeon or orthopedic doctor
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SF-SSRSSpine stereotactic radiosurgery/ablative radiotherapy (SSRS) with 16 Gy in single fraction to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). | Radiation | SF-SSRS |
| MF-SSRSSSRS with 24 Gy in three fractions to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Treatment should be given on every other day. Treatment on the consecutive days to the same target volume is not allowed. | Radiation | MF-SSRS |
Primary outcome
Common Toxicity Criteria for Adverse Events version 4 Grade 3 or higher adverse events related to spine radiosurgery
Time frame: 16 weeks after SSRS
The rate of 4-month Common Toxicity Criteria for Adverse Events version 4 grade 3 or higher adverse events definitely, probably or possibly related to treatment
8 secondary outcomes
The pain response rate at the treated index site(s) at 4 months by the numerical rating pain scale
Time frame: 16 weeks after Stereotactic Spine Radiosurgery
Health-related quality of life for palliative cancer care patients
Time frame: 1-, 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery
Local control rate at the treated index site(s)
Time frame: From date of enrolment until the date of first documented local progression or date of death from any cause, whichever came first, assessed up to 60 months
Acute toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: Within 90 days after Stereotactic Spine Radiosurgery
Late toxicity (Common Toxicity Criteria for Adverse Events version 4)
Time frame: From 90 days after Stereotactic Spine Radiosurgery until the date of death from any cause, up to 60 months
Changes of spinal cord function by Frankel's classification grading system for spine injury at 4 months
Time frame: 16 weeks after Stereotactic Spine Radiosurgery
Tumor-related spinal instability by the Spinal Instability Neoplastic Score (SINS) at 4 months.
Time frame: 16 weeks after Stereotactic Spine Radiosurgery
Osseous changes of the treated index site(s) on CT scan within 12 months
Time frame: 2-, 4-, 6-, 9-, and 12-month after Stereotactic Spine Radiosurgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
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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. This study is not recruiting at the moment.
Feng-Ming Hsu, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SF-SSRS and MF-SSRS in people with Secondary Malignant Neoplasm of Spine, 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 28 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 19 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Toxicity Criteria for Adverse Events version 4 Grade 3 or higher adverse events related to spine radiosurgery (time frame: 16 weeks after SSRS). 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 19 Jul 2019.