Secondary Malignant Neoplasm of SpineNCT04033536
Involved Versus Elective Target SSRS for Spinal Metastases
A study testing Involved Target Stereotacic Spine Radiosurgery and Elective Target Stereotacic Spine Radiosurgery in people with Secondary Malignant Neoplasm of Spine, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The spine is a common metastatic site for malignancy and it can lead to serious and devastating events, including pain, neurological dysfunction, and reduction in quality of life. The radiotherapy (RT) has been the mainstay for palliating painful spinal metastases for the past decades. 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?
- Involved Target Stereotacic Spine Radiosurgery and Elective Target Stereotacic Spine Radiosurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2019to Jun 2024
- 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
- Patients with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 20 years
- Karnofsky performance status (KPS) ≥ 60%.
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- Life expectancy of ≥ 6 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
Who cannot join
- Prior radiotherapy to the index spine(s)
- Serum creatinine > 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging 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
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- 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
- 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
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Feng-Ming Hsu, M.D., Ph.D., 886-2-23123456 ext. 62643, dr.hsufm@gmail.com
About this study
Official title: A Prospective Randomized Trial of Involved Versus Elective Target Definition in Stereotactic Spine Radiosurgery for Spinal Metastases
The spine is a common metastatic site for malignancy and it can lead to serious and devastating events, including pain, neurological dysfunction, and reduction in quality of life. The radiotherapy (RT) has been the mainstay for palliating painful spinal metastases for the past decades. It is utilized to arrest the tumor growth, control pain, and stabilize or improve skeletal and/or neurological function. One of the limitations of the conventional radiotherapy is that radiation dose intensification is not achievable with conventional RT techniques due to the dose-limiting spinal cord, which is close to the vertebral body and sometimes encased by epidural lesion.
The management of patients with spine metastasis has undergone a great deal of change in the past 10 years. The concept of radiosurgery, a high dose of radiation targeted to a pathological entity and delivered in 1-5-fractions, has proven so successful at treating both benign and malignant lesions that it changed the paradigm for radiation therapy. Clinical experiences with high dose spine stereotactic radiosurgery (SSRS) for spinal metastases demonstrated both safety and efficacy. Nontheless, the patterns of clinical practice of SSRS varies considerably regarding the dose fractionation, target delineation, and dosimetry. There is lack of evidence-based recommedations for SSRS.
In our prior clinical trial comparing single fraction and multiple fractions SSRS (NCT02608866), single-fraction with 16 Gy is the preferred regimen for further evaluation since it met the predefined primary endpoint and has lower risk of treatment failure compared to the multiple-fraction arm. Regarding the target volume definition, the International Spine Radiosurgery Consortium published concensus guidelines based on expert opinions and limited case series. We proposed this randomized study to determine the preferred or acceptable definition of target volume delineation in SSRS and to evaluate their toxicity, efficacy, and patterns of failure. Our analysis will provide evidence-based recommendations as well as predictive factors regarding the clinical practice of 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- assited 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 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 EBRT in patients with localized spine metastases. Our preliminary result from previus phase 2 stereotactic spine radiosurgery trial (NCT02608866) also showed good local control with minimal side effects in the single fraction 16-Gy setting as compared with 3 fractions 24 -Gy SRS dose.
Accurate and approproate delineation of the target area is paramount to the utilization of spine SBRT. Whethr the target volume should include the entire extent of tumor and the involved anatomical compartment for intact vertebra metastasis or remained to be discussed.
Our preliminary showed that the overall treatment failure rate was only about 14% using the definition of the treating the affected spinal lesions(invovled target ) instead of treating the entire . Better dose coverage of the target vome with improved normal tissue protection can be achived with invovled field treatment without compromising the local control. Since no treamtent target consensus has been reached from current clinical practive evidence. It is pivotal to establish and collect more treatment evidence for future spinal SBRT.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3 or higher adverse events between these two different target delineations. Thus, we proposed the randomized study to determine the feasibility of using "Invovled Target Volume" versus "Elective Target Volume" and tried to evaluate the toxicity profile and gain robust data as well as predictive factors regarding the local control rate and risk of complications after SSRS.
- Conditions
- Secondary Malignant Neoplasm of Spine
- Being tested
- Involved Target Stereotacic Spine Radiosurgery, Elective Target Stereotacic Spine Radiosurgery
- Keywords
- Spine metastasis, Stereotactic spine radiosurgery, Target definition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Involved Target Stereotacic Spine RadiosurgeryRadiation
Image guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Involved Target using IMRT/VMAT/RapidArc
Elective Target Stereotacic Spine RadiosurgeryRadiation
Image guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Elective Target using IMRT/VMAT/RapidArc
| Study group | Role | What they receive |
|---|---|---|
| Involved target SSRS | Active comparator | Spine stereotactic radiosurgery/ablative radiotherapy (SSRS) with 16 Gy in single fraction to the defined Involved Target Volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Receives: Radiation: Involved Target Stereotacic Spine Radiosurgery |
| Elective target SSRS | Active comparator | SSRS with 16 Gy in single fraction to the defined Elective Target Volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Receives: Radiation: Elective Target Stereotacic Spine Radiosurgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure Rate at 6 months after SSRS
The rate of predefined treatment failure at 6-month after stereotactic spine radiosurgery. Treatment failure is defined as Grade 3 or higher adverse events definitely, probably, or possibly related to treatment and/or unequivocal local progression indicative of surgical intervention or re-irradiation.
Measured: 6 months
Secondary outcomes (1)
Health-related quality of life for palliative cancer care
EORTC QLQ-C15-PAL Taiwan
Measured: 1-, 3-, and 6-month, and every 3 months thereafter until neurological progression, death, or up to 1 year after SSRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study startAug 2019 (estimated)
- Primary completionJun 2022 (estimated)
- Study completionJun 2024 (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
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng-Ming Hsu, M.D., Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033536
- Sponsor's protocol ID
- 201905015RINC
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Involved Versus Elective Target Definition in Stereotactic Spine Radiosurgery for Spinal Metastases
- ClinicalTrials.gov ID
- NCT04033536
- Acronym / sponsor ID
- 201905015RINC
- Conditions
- Secondary Malignant Neoplasm of Spine
- Keywords
- Spine metastasis, Stereotactic spine radiosurgery, Target definition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 26 Jul 2019 (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.
The spine is a common metastatic site for malignancy and it can lead to serious and devastating events, including pain, neurological dysfunction, and reduction in quality of life. The radiotherapy (RT) has been the mainstay for palliating painful spinal metastases for the past decades. It is utilized to arrest the tumor growth, control pain, and stabilize or improve skeletal and/or neurological function. One of the limitations of the conventional radiotherapy is that radiation dose intensification is not achievable with conventional RT techniques due to the dose-limiting spinal cord, which is close to the vertebral body and sometimes encased by epidural lesion.
The management of patients with spine metastasis has undergone a great deal of change in the past 10 years. The concept of radiosurgery, a high dose of radiation targeted to a pathological entity and delivered in 1-5-fractions, has proven so successful at treating both benign and malignant lesions that it changed the paradigm for radiation therapy. Clinical experiences with high dose spine stereotactic radiosurgery (SSRS) for spinal metastases demonstrated both safety and efficacy. Nontheless, the patterns of clinical practice of SSRS varies considerably regarding the dose fractionation, target delineation, and dosimetry. There is lack of evidence-based recommedations for SSRS.
In our prior clinical trial comparing single fraction and multiple fractions SSRS (NCT02608866), single-fraction with 16 Gy is the preferred regimen for further evaluation since it met the predefined primary endpoint and has lower risk of treatment failure compared to the multiple-fraction arm. Regarding the target volume definition, the International Spine Radiosurgery Consortium published concensus guidelines based on expert opinions and limited case series. We proposed this randomized study to determine the preferred or acceptable definition of target volume delineation in SSRS and to evaluate their toxicity, efficacy, and patterns of failure. Our analysis will provide evidence-based recommendations as well as predictive factors regarding the clinical practice of 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- assited 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 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 EBRT in patients with localized spine metastases. Our preliminary result from previus phase 2 stereotactic spine radiosurgery trial (NCT02608866) also showed good local control with minimal side effects in the single fraction 16-Gy setting as compared with 3 fractions 24 -Gy SRS dose.
Accurate and approproate delineation of the target area is paramount to the utilization of spine SBRT. Whethr the target volume should include the entire extent of tumor and the involved anatomical compartment for intact vertebra metastasis or remained to be discussed.
Our preliminary showed that the overall treatment failure rate was only about 14% using the definition of the treating the affected spinal lesions(invovled target ) instead of treating the entire . Better dose coverage of the target vome with improved normal tissue protection can be achived with invovled field treatment without compromising the local control. Since no treamtent target consensus has been reached from current clinical practive evidence. It is pivotal to establish and collect more treatment evidence for future spinal SBRT.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3 or higher adverse events between these two different target delineations. Thus, we proposed the randomized study to determine the feasibility of using "Invovled Target Volume" versus "Elective Target Volume" and tried to evaluate the toxicity profile and gain robust data as well as predictive factors regarding the local control rate and risk of complications after SSRS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Involved target SSRS | Active comparator | Radiation: Involved Target Stereotacic Spine RadiosurgerySpine stereotactic radiosurgery/ablative radiotherapy (SSRS) with 16 Gy in single fraction to the defined Involved Target Volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). |
| Elective target SSRS | Active comparator | Radiation: Elective Target Stereotacic Spine RadiosurgerySSRS with 16 Gy in single fraction to the defined Elective Target Volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). |
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 with a histologic diagnosis of non-hematopoietic malignancy
- Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion
- Maximum four separate sites with a maximal involvement of two continuous vertebral levels
- Patients do not have prior radiotherapy to the index spine(s)
- Age ≥ 20 years
Key exclusion criteria (10 listed)
- Prior radiotherapy to the index spine(s)
- Serum creatinine > 2.0 mg/dL within 90 days prior registration
- Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia
- Patients with leptomeningeal involvement or intramedullary metastasis
- Inability to tolerate treatment procedure
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 |
|---|---|---|
| Involved Target Stereotacic Spine RadiosurgeryImage guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Involved Target using IMRT/VMAT/RapidArc | Radiation | Involved target SSRS |
| Elective Target Stereotacic Spine RadiosurgeryImage guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Elective Target using IMRT/VMAT/RapidArc | Radiation | Elective target SSRS |
Primary outcome
Treatment Failure Rate at 6 months after SSRS
Time frame: 6 months
The rate of predefined treatment failure at 6-month after stereotactic spine radiosurgery. Treatment failure is defined as Grade 3 or higher adverse events definitely, probably, or possibly related to treatment and/or unequivocal local progression indicative of surgical intervention or re-irradiation.
1 secondary outcome
Health-related quality of life for palliative cancer care
Time frame: 1-, 3-, and 6-month, and every 3 months thereafter until neurological progression, death, or up to 1 year after SSRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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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, M.D., Ph.D 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 Involved Target Stereotacic Spine Radiosurgery and Elective Target Stereotacic Spine Radiosurgery 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 9 inclusion and 10 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 26 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?
Contact Feng-Ming Hsu, M.D., Ph.D (886-2-23123456 ext. 62643, dr.hsufm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure Rate at 6 months after SSRS (time frame: 6 months). 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 26 Jul 2019.