Vertebral MetastasisNCT01654068
Conformal High Dose Intensity Modulated Radiation Therapy for Disease to Thoracic and Lumbar Spine
A study testing Conformal High Dose Intensity Modulated Radiation Therapy in people with Vertebral Metastasis, run by Ronald McGarry at 1 site in United States.
Trial summary
The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Metastasis
- What is being tested?
- Conformal High Dose Intensity Modulated Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2009to 8 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histological confirmation of malignancy (non-small cell lung cancer, breast cancer (hormone refractory), prostate cancer (hormone refractory), lymphoma, renal cell carcinoma, myeloma by either biopsy or cytology of the primary or metastatic lesion.
- Patients must have radiological documentation of metastatic disease to the thoracic or lumbar spine including both positron emitted tomography (PET) or nuclear medicine bone scan (NMBS) and Magnetic Resonance Imaging (MRI) within 4 weeks prior to study entry.
- Patients with one to three spinal metastases to the thoracic or lumbar spine will be included.
- Spinal metastatic lesions should be limited to one vertebral body level or ≤ 6cm in greatest dimension.
- Tumors should not directly abut the spinal cord, and have at least 5mm separation from the spinal cord. For patients with tumors closer than 5mm, inclusion is permissible at the discretion of the treating radiation oncologist such that dosimetric review demonstrates that the total dose to spinal cord is within tolerable range of <10Gy to 10% partial volume or max point dose 18 Gy.
- Patients must be able to fit into either the Elekta Stereotactic Body Frame or the Elekta Stereotactic BodyFix immobilization device.
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- Must be ≥ 18 years of age.
- ECOG status 0-2.
- Women of childbearing potential and male participants must use an effective contraception method. (Until at least 60 days following treatment.)
- Negative urine pregnancy test within at least one week before starting treatment in women of child-bearing age.
- Patients must sign a study-specific informed consent form.
Who cannot join
- Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures.
- Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their current cancer prior to therapy that, in the investigator's opinion, would preclude their inclusion.
- Patient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment. Patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemia.
- Pregnant or lactating women.
- Any patient with symptoms of pain, compression fracture, neurologic deficit will not be included.
- Patients previously treated with radiation therapy to the thoracic or lumbar spinal levels of involved disease will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine
The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.
- Conditions
- Vertebral Metastasis
- Being tested
- Conformal High Dose Intensity Modulated Radiation Therapy
- Keywords
- Female Breast Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Vertebral metastasis
- Medical subject headings
- Kidney Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conformal High Dose Intensity Modulated Radiation TherapyRadiation
Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy to Local Spine Metastasis | Experimental | Conformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis. Receives: Radiation: Conformal High Dose Intensity Modulated Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Any Skeletal Related Event
Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).
Measured: up to 24 months
Secondary outcomes (2)
Acute Radiation Toxicity
The number of acute side effects of radiation therapy will be documented (≤ 90 days from start of radiation therapy)
Measured: 90 days
Late Radiation Toxicity
The number of late side effects of radiation therapy will be documented (> 90 days after the start of radiation therapy)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study start9 Dec 2009
- Primary completion22 Apr 2016
- Study completion8 Sep 2016
Why it stopped: low participant accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vertebral MetastasisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronald McGarry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronald McGarry, University of Kentucky
- Investigators
- Ronald McGarry, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654068
- Sponsor's protocol ID
- MCC-09-RAD-01
- Status last verified
- Mar 2019
- First submitted
- 17 Jul 2012
- Last updated
- 19 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conformal High Dose Intensity Modulated Radiation Therapy for Asymptomatic Metastatic Disease to the Thoracic and Lumbar Spine
- ClinicalTrials.gov ID
- NCT01654068
- Acronym / sponsor ID
- MCC-09-RAD-01
- Conditions
- Vertebral Metastasis
- Keywords
- Female Breast Cancer, Kidney Cancer, Lung Cancer, Prostate Cancer, Vertebral metastasis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low participant accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ronald McGarryUniversity, hospital or other
- Study start
- 9 Dec 2009 (actual)
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 19 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if Conformal High Dose Intensity Modulated Radiation Therapy is an appropriate option for treating cancer that has spread to the spinal column. This study involves patients who have been diagnosed with metastatic cancer to the thoracic and lumbar vertebral body levels and currently do not have symptoms caused from the area of concern. The goal is to prove that this is not only a safe form of treatment, but that Conformal High Dose Intensity Modulated Radiation Therapy can reduce the risk of cancer coming back in the area that the investigators treat which may reduce the risk of developing symptoms like pain in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy to Local Spine Metastasis | Experimental | Radiation: Conformal High Dose Intensity Modulated Radiation TherapyConformal High Dose Intensity Modulated Radiation Therapy to a single asymptomatic local spine metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histological confirmation of malignancy (non-small cell lung cancer, breast cancer (hormone refractory), prostate cancer (hormone refractory), lymphoma, renal cell carcinoma, myeloma by either biopsy or cytology of the primary or metastatic lesion.
- Patients must have radiological documentation of metastatic disease to the thoracic or lumbar spine including both positron emitted tomography (PET) or nuclear medicine bone scan (NMBS) and Magnetic Resonance Imaging (MRI) within 4 weeks prior to study entry.
- Patients with one to three spinal metastases to the thoracic or lumbar spine will be included.
- Spinal metastatic lesions should be limited to one vertebral body level or ≤ 6cm in greatest dimension.
- Tumors should not directly abut the spinal cord, and have at least 5mm separation from the spinal cord. For patients with tumors closer than 5mm, inclusion is permissible at the discretion of the treating radiation oncologist such that dosimetric review demonstrates that the total dose to spinal cord is within tolerable range of <10Gy to 10% partial volume or max point dose 18 Gy.
Key exclusion criteria (6 listed)
- Patients with evidence of spinal instability OR neurologic deficit resulting from bony compression of neurologic structures.
- Patients with other systemic illness, or have not recovered adequately from their primary treatment or who have evidence of progression of their current cancer prior to therapy that, in the investigator's opinion, would preclude their inclusion.
- Patient may not receive concomitant cytotoxic anti-neoplastic therapy during treatment. Patients may be allowed to use hormonal suppression therapy or bisphosphonates for hypercalcemia.
- Pregnant or lactating women.
- Any patient with symptoms of pain, compression fracture, neurologic deficit will not be included.
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 |
|---|---|---|
| Conformal High Dose Intensity Modulated Radiation TherapyConformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons | Radiation | Radiation Therapy to Local Spine Metastasis |
Primary outcome
Time to Any Skeletal Related Event
Time frame: up to 24 months
Time to any skeletal related event most commonly symptomatic recurrence or progression with pain/neurologic impairment with evidence of radiographic progression (median local progression-free survival).
2 secondary outcomes
Acute Radiation Toxicity
Time frame: 90 days
Late Radiation Toxicity
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ronald McGarry, M.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conformal High Dose Intensity Modulated Radiation Therapy in people with Vertebral Metastasis, run by Ronald McGarry 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 11 inclusion and 6 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: stopped early, as of the sponsor's last update on 19 Apr 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 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?
Yes. Results are posted in the registry (first posted 19 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Any Skeletal Related Event (time frame: up to 24 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 19 Apr 2019.