Metastatic Epidural Spinal Cord CompressionPhase 1NCT01256554
Single Session Spine Stereotactic Radiosurgery in Metastatic Epidural Spinal Cord Compression
A Phase 1 study testing Stereotactic Radiosurgery (SSRS) and Questionnaires in people with Metastatic Epidural Spinal Cord Compression, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Epidural Spinal Cord Compression
- What is being tested?
- Stereotactic Radiosurgery (SSRS) and Questionnaires
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2010to 15 Oct 2021
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Greater than or equal to 18 years old
- Radiographically documented metastatic epidural compression on spine Magnetic resonance imaging (MRI) within 4 weeks of registration, defined radiographically, ranging from minimal canal compromise and thecal indentation to actual displacement of the spinal cord.
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- Signed Informed consent for irradiation
- Diagnosis of cancer including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
- Motor Strength >/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
Show all 9Show fewer
- Karnofsky performance status (KPS) >/= 40
- Patients deemed to be inoperable due to patient refusal, by neurosurgical evaluation, or for any reason
- 1 prior course of spine radiotherapy to the current region of interest
Who cannot join
- Prior irradiation of the site to be treated </= 3 months prior to registration
- Inability to tolerate lying flat on treatment table for greater than 30 minutes.
- Patients unable to undergo MRI of the spine
- Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or similar biologically effective dose (BED) to the area of the spine to be treated. Below are the normalized BED at 2 Gy per fraction with alpha/beta=2 for spinal cord in commonly used fractionation schemes in previously irradiated patients. Conventional Radiotherapy (Normalized Biologically Effective Dose) 20 Gy in 5 fractions(30 Gy 2/2), 30 Gy in 10 fractions(37.5 Gy 2/2), 37.5 Gy in 15 fractions(42 Gy 2/2), 40 Gy in 20 fractions(40 Gy 2/2), 45 Gy in 25 fractions(43 Gy 2/2), 50 Gy in 25 fractions(50 Gy 2/2) following equation: nBED is calculated by dividing BED by (1 + d/a/b), where d is 2 Gy and for spinal cord late effect a/b is 2, and we describe the units as Gy 2/2 (i.e., Gy 2/2 = 2-Gy equivalent with a/b = 2)
- Patients who are pregnant.
- Patients who have cord compression from bone components or configuration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management of Patients With Inoperable, Previously Irradiated Metastatic Epidural Spinal Cord Compression (MESCC)
The goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.
Read the detailed description
Spinal cord compression is often treated with surgery followed by radiation in small doses every day for a number of days. When a patient cannot or will not have surgery, radiation is given daily. With increased accuracy and precision, higher doses of radiation can be given in a single session. Giving a higher dose in a single session may increase the chance that the tumor will stop growing into the spinal canal and will prevent spinal cord injury. This study will also help to identify the tolerance of the spinal cord to radiation in a single session.
Spine Stereotactic Radiosurgery:
You will lie in the mold that was made for you for 45-120 minutes while you receive your radiation treatment.
Follow-up Visits:
You will have follow-up visits at Months 3 (+/-2 weeks ), 6 (+/-4 weeks), 9 (+/-4 weeks), 12 (+/-8 weeks), 18 (+/-8 weeks), and 24 (+/-8 weeks) and then every 6 months after that. At each follow-up visit:
- Your medical history will be recorded, including usage of steroids.
- You will have a neurological exam.
- You will complete the 3 questionnaires about health, symptoms you may be having, and about pain.
- You will have an MRI of the spine.
If you are unable to return for follow-up clinic visits, you will be called and asked about your medical history, and you will complete the 3 questionnaires about your health, symptoms you may be having, and about pain. This call should take about 20 minutes.
Length of Study:
Your treatment will last 1 day. You will continue having follow-up visits or phone calls for as long as possible.
This is an investigational study. SSRS is FDA approved. The use of SSRS to treat metastatic epidural spinal cord compression is investigational.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Stereotactic Radiosurgery (SSRS), Questionnaires
- Keywords
- Stereotactic Radiosurgery, SSRS, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Radiosurgery (SSRS)Procedure or surgery
Also called Stereotactic Radiosurgery, SSRS, Radiation, Radiotherapy
Target dose of 18 or 24 Gy to spine in single session of radiation.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery (SSRS) | Experimental | Target dose of 18 or 24 Gy to spine in single session of radiation. Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months. Receives: Procedure: Stereotactic Radiosurgery (SSRS); Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
Maximum acceptable Dmax will be that in which there are fewer RM events than TP events prior to 12 months and less than 2 RM events.
Measured: Up to 12 months following radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study start3 Dec 2010
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Epidural Spinal Cord CompressionStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amol J. Ghia, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256554
- Sponsor's protocol ID
- 2010-0653
- Other IDs
- NCI-2011-00273
- Status last verified
- Oct 2021
- First submitted
- 7 Dec 2010
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management of Patients With Inoperable, Previously Irradiated Metastatic Epidural Spinal Cord Compression (MESCC)
- ClinicalTrials.gov ID
- NCT01256554
- Acronym / sponsor ID
- 2010-0653
- Keywords
- Stereotactic Radiosurgery, SSRS, Radiation, Radiotherapy, Metastatic Epidural Spinal Cord Compression, MESCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 3 Dec 2010 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 8 Dec 2010 (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 goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.
Detailed description
Spinal cord compression is often treated with surgery followed by radiation in small doses every day for a number of days. When a patient cannot or will not have surgery, radiation is given daily. With increased accuracy and precision, higher doses of radiation can be given in a single session. Giving a higher dose in a single session may increase the chance that the tumor will stop growing into the spinal canal and will prevent spinal cord injury. This study will also help to identify the tolerance of the spinal cord to radiation in a single session.
Spine Stereotactic Radiosurgery:
You will lie in the mold that was made for you for 45-120 minutes while you receive your radiation treatment.
Follow-up Visits:
You will have follow-up visits at Months 3 (+/-2 weeks ), 6 (+/-4 weeks), 9 (+/-4 weeks), 12 (+/-8 weeks), 18 (+/-8 weeks), and 24 (+/-8 weeks) and then every 6 months after that. At each follow-up visit:
- Your medical history will be recorded, including usage of steroids.
- You will have a neurological exam.
- You will complete the 3 questionnaires about health, symptoms you may be having, and about pain.
- You will have an MRI of the spine.
If you are unable to return for follow-up clinic visits, you will be called and asked about your medical history, and you will complete the 3 questionnaires about your health, symptoms you may be having, and about pain. This call should take about 20 minutes.
Length of Study:
Your treatment will last 1 day. You will continue having follow-up visits or phone calls for as long as possible.
This is an investigational study. SSRS is FDA approved. The use of SSRS to treat metastatic epidural spinal cord compression is investigational.
Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery (SSRS) | Experimental | Procedure: Stereotactic Radiosurgery (SSRS), Behavioral: QuestionnairesTarget dose of 18 or 24 Gy to spine in single session of radiation. Questionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Greater than or equal to 18 years old
- Radiographically documented metastatic epidural compression on spine Magnetic resonance imaging (MRI) within 4 weeks of registration, defined radiographically, ranging from minimal canal compromise and thecal indentation to actual displacement of the spinal cord.
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- Signed Informed consent for irradiation
- Diagnosis of cancer including but not limited to non-small cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma, thyroid, head and neck primary, and unknown primary tumors
Key exclusion criteria (6 listed)
- Prior irradiation of the site to be treated </= 3 months prior to registration
- Inability to tolerate lying flat on treatment table for greater than 30 minutes.
- Patients unable to undergo MRI of the spine
- Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or similar biologically effective dose (BED) to the area of the spine to be treated. Below are the normalized BED at 2 Gy per fraction with alpha/beta=2 for spinal cord in commonly used fractionation schemes in previously irradiated patients. Conventional Radiotherapy (Normalized Biologically Effective Dose) 20 Gy in 5 fractions(30 Gy 2/2), 30 Gy in 10 fractions(37.5 Gy 2/2), 37.5 Gy in 15 fractions(42 Gy 2/2), 40 Gy in 20 fractions(40 Gy 2/2), 45 Gy in 25 fractions(43 Gy 2/2), 50 Gy in 25 fractions(50 Gy 2/2) following equation: nBED is calculated by dividing BED by (1 + d/a/b), where d is 2 Gy and for spinal cord late effect a/b is 2, and we describe the units as Gy 2/2 (i.e., Gy 2/2 = 2-Gy equivalent with a/b = 2)
- Patients who are pregnant.
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 |
|---|---|---|
| Stereotactic Radiosurgery (SSRS)Also: Stereotactic Radiosurgery, SSRS, Radiation, RadiotherapyTarget dose of 18 or 24 Gy to spine in single session of radiation. | Procedure or surgery | Stereotactic Radiosurgery (SSRS) |
| QuestionnairesAlso: SurveysQuestionnaire completion about health symptoms and pain at baseline, 3 months, 6 months, 9 months, 12 months, 24 months, then every 6 months. | Behavioural | Stereotactic Radiosurgery (SSRS) |
Primary outcome
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM)
Time frame: Up to 12 months following radiation
Maximum acceptable Dmax will be that in which there are fewer RM events than TP events prior to 12 months and less than 2 RM events.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Metastatic Epidural Spinal Cord Compression
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Metastatic Epidural Spinal Cord Compression
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
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Risk Adapted Spinal Cord/Cauda Constraint Relaxation for High-risk Patients With Metastatic Epidural Spinal Cord Compression Undergoing Spine Stereotactic Radiosurgery
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Postoperative Edge (RapidArc) Stereotactic Body Radiotherapy for Spinal Metastases
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Miami "RADAR" Trial
Metastatic Epidural Spinal Cord Compression, Spinal Cord Compression
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.
Amol J. Ghia, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiosurgery (SSRS) and Questionnaires in people with Metastatic Epidural Spinal Cord Compression, run by M.D. Anderson Cancer Center 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 9 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: finished, as of the sponsor's last update on 25 Oct 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Occurrences of Paralysis Caused by Radiation Myelitis (RM) (time frame: Up to 12 months following radiation). 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 25 Oct 2021.