OncologyNCT04375891
Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation
A study testing Radiation Therapy and Radiofrequency Ablation (RFA) in people with Oncology and Spine Metastases, run by Baptist Health South Florida at 1 site in United States.
Trial summary
The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Spine Metastases
- What is being tested?
- Radiation Therapy and Radiofrequency Ablation (RFA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2020to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have localized spine metastasis from the T5 to L5 levels by an imaging study (bone scan, PET, CT, or MRI). Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible.
- Zubrod Performance Status 0-3
- History/physical examination within 2 weeks prior to registration
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;
- MRI (contrast is not required but strongly recommended) of the involved spine within 6 weeks prior to registration to determine the extent of the spine involvement;
- Numerical Rating Pain Scale within 1 week prior to registration; the patient must have a score on the Scale of ≥ 5 for at least one of the planned sites for intervention. Documentation of the patient's initial pain score is required. Patients taking medication for pain at the time of registration are eligible.
- Patients with epidural compression are eligible provided that there is a ≥ 3 mm gap between the spinal cord and the edge of the epidural lesion.
- Patients must provide study specific informed consent prior to study entry.
Who cannot join
- Histologies of myeloma, lymphoma, small-cell lung cancer, germ-cell tumor
- Non-ambulatory patients;
- Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord;
- Patients with rapid neurologic decline;
- Bony retropulsion causing neurologic abnormality;
- Prior radiation to the index spine
Show all 9Show fewer
- Patients requiring immediate neurosurgical intervention
- Patients receiving concurrent chemotherapy
- Patients needing palliative to more than 2 sites of spinal disease in total
Trial locations and contacts
1 site in 1 country.
United States1 site
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176
About this study
Official title: Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation for Localized Spine Metastasis
The spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.
Read the detailed description
All supportive therapy for optimal medical care will be given during the study period at the discretion of the attending physician(s) within the parameters of the protocol and documented on each site's source documents as concomitant medication.
The study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
Patients will be stratified according to the tumor type (radioresistant [soft tissue sarcoma, melanoma, and renal cell carcinoma] versus other types). The treatment allocation scheme described by Zelen (1974) will be used because it balances patient factors. Within each stratum, patients will be randomized in a 2:1 ratio to either image-guided RT plus RFA/PVA or external beam RT alone.
The 2:1 randomization allocation will be used to accommodate increased demand for image-guided RT plus RFA/PVA.
- Conditions
- Oncology, Spine Metastases
- Being tested
- Radiation Therapy, Radiofrequency Ablation (RFA)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
30 Gy in 10 fractions of 3 Gy each
Radiofrequency Ablation (RFA)Radiation
Radiofrequency Ablation (RFA) / Vertebral Augmentation
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Other | Radiotherapy alone Receives: Radiation: Radiation Therapy |
| Radiotherapy plus radiofrequency ablation | Other | Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy) Receives: Radiation: Radiation Therapy; Radiation: Radiofrequency Ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain control
Change in pain control (as measured by the 11 point Numeric pain rating scale) as compared to conventional palliative radiotherapy alone.
Measured: 3 months, 6, 12, 24 months
Secondary outcomes (4)
Change in pain response
Change in the rapidity of pain response at the treated site(s) as compared to conventional Radiotherapy alone, as measured by the Numeric pain rating scale.
Measured: 3 months, 6, 12, 24 months
Measure increases in the duration of pain response
Measure increases in the duration of pain response at the treated site(s), as compared to conventional RT alone, as measured by the Numeric pain rating scale.
Measured: 3 months, 6, 12, 24 months
Number of adverse events
Number of adverse events between the two treatments according to the NCI Common Terminology Criteria for Adverse Events version 5.0.
Measured: 3 months, 6, 12, 24 months
Measure the potential benefit on quality of life
Measure the potential benefit of radiotherapy plus Vertebral Augmentation/Radiofrequency Ablation on change in and overall quality of life, as measured by the Functional Assessment of Cancer Therapy-General; in pain as measured by the Brief Pain Inventory; and in health utilities as measured by the EuroQol
Measured: 3 months, 6, 12, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start22 May 2020
- Primary completionOct 2025 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A study design of 2:1 randomization scheme (RT plus PVA/RFA:RT), the study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Rupesh Kotecha, MD, Principal investigator, Miami Cancer Institute (MCI) at Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375891
- Sponsor's protocol ID
- 2018-KOT-001
- Status last verified
- Feb 2025
- First submitted
- 13 Mar 2020
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kotecha R, Schiro BJ, Sporrer J, Rubens M, Appel HR, Calienes KS, Boulanger B, Pujol MV, Suarez DT, Pena A, Kudryashev A, Mehta MP. Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial. Trials. 2020 Nov 23;21(1):964. doi: 10.1186/s13063-020-04895-x.
PubMed 33228756
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation for Localized Spine Metastasis
- ClinicalTrials.gov ID
- NCT04375891
- Acronym / sponsor ID
- 2018-KOT-001
- Conditions
- Oncology, Spine Metastases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 22 May 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 May 2020 (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 spread of cancer to the spine is referred to as spine metastasis. Spine metastases are a common complication of cancer and are frequently associated with significant back pain. This study is being done to help improve treatment for back pain caused by spinal metastases by comparing the effectiveness of two standard treatments. These two treatments include radiation therapy (RT) alone versus radiation therapy combined with radiofrequency ablation, with or without vertebral augmentation (PVA/RFA). In addition to RT or RT with PVA/RFA, will be continued with current pain medications.
Detailed description
All supportive therapy for optimal medical care will be given during the study period at the discretion of the attending physician(s) within the parameters of the protocol and documented on each site's source documents as concomitant medication.
The study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
Patients will be stratified according to the tumor type (radioresistant [soft tissue sarcoma, melanoma, and renal cell carcinoma] versus other types). The treatment allocation scheme described by Zelen (1974) will be used because it balances patient factors. Within each stratum, patients will be randomized in a 2:1 ratio to either image-guided RT plus RFA/PVA or external beam RT alone.
The 2:1 randomization allocation will be used to accommodate increased demand for image-guided RT plus RFA/PVA.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A study design of 2:1 randomization scheme (RT plus PVA/RFA:RT), the study will be adequately powered with 52 patients (35 in the RT plus PVA/RFA arm and 17 in the RT arm). Assuming a 5% ineligibility rate, a death rate of 15%, and a patient non-compliance rate of 15%, the total sample size required would be 80 patients.
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Other | Radiation: Radiation TherapyRadiotherapy alone |
| Radiotherapy plus radiofrequency ablation | Other | Radiation: Radiation Therapy, Radiation: Radiofrequency Ablation (RFA)Radiotherapy plus radiofrequency ablation / vertebral augmentation(Combination therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The patient must have localized spine metastasis from the T5 to L5 levels by an imaging study (bone scan, PET, CT, or MRI). Patients can have other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible.
- Zubrod Performance Status 0-3
- History/physical examination within 2 weeks prior to registration
- Negative serum pregnancy test within 2 weeks prior to registration for women of childbearing potential; Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control;
- MRI (contrast is not required but strongly recommended) of the involved spine within 6 weeks prior to registration to determine the extent of the spine involvement;
Key exclusion criteria (9 listed)
- Histologies of myeloma, lymphoma, small-cell lung cancer, germ-cell tumor
- Non-ambulatory patients;
- Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord;
- Patients with rapid neurologic decline;
- Bony retropulsion causing neurologic abnormality;
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 |
|---|---|---|
| Radiation Therapy30 Gy in 10 fractions of 3 Gy each | Radiation | Radiotherapy, Radiotherapy plus radiofrequency ablation |
| Radiofrequency Ablation (RFA)Radiofrequency Ablation (RFA) / Vertebral Augmentation | Radiation | Radiotherapy plus radiofrequency ablation |
Primary outcome
Change in pain control
Time frame: 3 months, 6, 12, 24 months
Change in pain control (as measured by the 11 point Numeric pain rating scale) as compared to conventional palliative radiotherapy alone.
4 secondary outcomes
Change in pain response
Time frame: 3 months, 6, 12, 24 months
Measure increases in the duration of pain response
Time frame: 3 months, 6, 12, 24 months
Number of adverse events
Time frame: 3 months, 6, 12, 24 months
Measure the potential benefit on quality of life
Time frame: 3 months, 6, 12, 24 months
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 4 Feb 2025.
- Derived from this study: PubMed 33228756Kotecha R, Schiro BJ, Sporrer J, Rubens M, Appel HR, Calienes KS, Boulanger B, Pujol MV, Suarez DT, Pena A, Kudryashev A, Mehta MP. Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for spine metastasis: study protocol for a randomized controlled trial. Trials. 2020 Nov 23;21(1):964. doi: 10.1186/s13063-020-04895-x.
- Miami Cancer Institute websiteLink provided by the sponsor.
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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.
Rupesh Kotecha, MD principal investigator
Miami Cancer Institute (MCI) at Baptist Health South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy and Radiofrequency Ablation (RFA) in people with Oncology and Spine Metastases, run by Baptist Health South Florida at 1 site in United States.
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 8 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2025. 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 United States. 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?
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?
Change in pain control (time frame: 3 months, 6, 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375891, which also lists 1 linked publication.
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 4 Feb 2025.