search
Back to results

MRIdian "RADAR" Trial

Primary Purpose

Metastatic Epidural Spinal Cord Compression, Spinal Cord Compression

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ViewRay MRIdian Stereotactic Radiosurgery
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Epidural Spinal Cord Compression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female participants ages ≥ 18. Solid tumors causing MESCC for which surgery is an option as first-line treatment. Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria. MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement. Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI. Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels. Karnofsky performance score ≥60 Survival prognosis ≥3 months Medical status allowing surgery. Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression. Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function). All patients must be ambulatory. Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment) Spine instability neoplastic score < 14 a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery. Willing and able to undergo daily MRI during treatment Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 History and physical within 2 weeks prior to registration Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: Unknown primary histology Patients with rapid neurologic decline. Bony retropulsion causing neurologic abnormality Non-ambulatory patients. Prior radiation to the involved site. Inability to have an MRI Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases) Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma) Patients with impaired decision-making capacity.

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ViewRay MRidian

Arm Description

Participants will receive five (5) doses of radiation therapy over four (4) weeks. The first dose will be given during week 1; after at least 36 hours from the first dose, participants will receive the second dose. The remaining doses will be three (3) doses will be administered once per week during weeks 2, 3, and 4. The treatment plan may change at the discretion of the treating physician. Participants will have three additional doses each week in Weeks 2, 3, and 4.

Outcomes

Primary Outcome Measures

One-year failure rate
The one-year failure rate is determined by the number of study participants with clinical failure, defined as needing decompressive surgery at the targeted spinal area due to progression of disease. The rate is determined by the amount of participants with documented clinical failure at any time within ten months of completing protocol therapy. This number is compared to the rate of decompressive surgery in the general population.

Secondary Outcome Measures

Rate of radiation myelopathy
The rate of radiation myelopathy will assess the proportion of patients with neurologic deterioration prior to starting protocol therapy to six months after completing protocol therapy. This is determined using the modified McKenzie scores and will be scored by the treating physician. Scores are A: no abnormality, B: focal minor symptom (e.g. pain), C: functional paresis, D: nonfunctional paresis, and E: paralysis or incontinence. The treating physician will determine if scores are probably or definitely related to protocol therapy and not to local progression of tumor.
Rate of vertebral compression fracture
The rate of vertebral compression fracture (VCF) is determined by the number of participants who develop VCF possibly, probably, or definitely related to the protocol therapy, as opposed to tumor progression. This is assessed and determined by the treating physician by reviewing the initial MRI done prior to starting protocol therapy compared to MRI scans done at follow up visits after receiving protocol therapy.
Number of Treatment Related Adverse Events as Measured By CTCAE v.5
The number of treatment-related adverse events during the study will be assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 3 months of completing the protocol therapy that are determined to be grades 2 or higher (acute toxicity) by the treating physician.
Local control (LC) rate
The local control (LC) is defined as the absence of progression of the disease at the treated spinal area. The LC rate is assessed by comparing two separate MRI scans - the initial MRI done prior to starting therapy compared to the MRI done one month after completing protocol therapy. The rate is determined by assessing progression of disease between the two MRI scans.
Local progression (LP) rate
The local progression (LP) is defined as the unequivocal increase in tumor volume or linear dimension, any new or progressive tumor within the treated area; or neurological deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions. The LP rate is assessed by comparing two separate MRI scans - the initial MRI done prior to starting therapy compared to the MRI done one month after completing protocol therapy.
Change in mean relative in epidural tumor
The mean relative epidural tumor reduction measures the tumor size assessed on the initial MRI scan done prior to starting protocol therapy compared to the tumor size assessed on MRI scan done one month after completing protocol therapy.
Overall epidural tumor response rate
The overall epidural tumor response rate is determined by the objective response rate (ORR) which is defined by the number of participants with objective response to protocol therapy compared to overall number of study participants. This rate is determined based on review of two MRI scans - the initial MRI scan done prior to starting protocol therapy compared to the MRI scan done one month after completing protocol therapy.
Change in mean relative thecal sac patency
The change in mean relative thecal sac patency is defined as [(postradiosurgery thecal sac area minus preradiosurgery thecal sac area) divided by pre radiosurgery thecal sac area].
Change in thecal sac decompression rate
The change in thecal sac decompression rate is defined as the number of study participants who experienced a relative improvement of thecal sac patency at 1 month post-radiotherapy (post-RT) MRI divided by the total number of study participants.
In-field progression (IFP) rate
The in-field progression (IFP) rate is defined as the proportion of patients with in-field progression, where IFP is defined as the increase in tumor size, any new or progressive tumor within the treatment area, or neurological deterioration attributable to preexisting disease in treatment area. This is determined based on review of two MRI scans - the initial MRI scan done prior to starting protocol therapy compared to the MRI done one month after completing protocol therapy.
Distant progression (DP) rate
The distant progression (DP) rate is defined as the proportion of patients who experience DP, where DP is defined as the increase in tumor size or any new or progressive tumor outside of the treatment area.
Failure-Free Survival (FFS)
The failure-free survival (FFS) is defined as the time from study enrollment to the first documented clinical failure or death from any cause, whichever occurs first.
Overall Survival (OS)
The overall survival (OS) is defined as the time from study enrollment to the time of first documented death from any cause.
Quality of Life Assessed Using EuroQol (EQ) Five Dimension (5D) Five Level (5L) (EQ-5D-5L)
The EQ-5D-5L represents a global quality of life measure that includes multiple components. The EQ-5D-5L score includes questions on mobility, self-care, usual activities, anxiety/depression, and pain/discomfort on a 5-point scale: 1=No Problem, 2=Slight Problem, 3=Moderate Problem, 4=Severe Problem, 5=Extreme Problem or Inability. 0, 1, and negative values correspond to death, full health, and health states worse than death, respectively. Higher scores indicate greater levels of problems across each of the five dimensions.
Quality of Life Assessed Using FACT-G
Defined by the Functional Assessment of Cancer Therapy General (FACT-G), a 27-item questionnaire designed to measure four domains of health-related QOL in cancer participants. Items are rated on a 5-item Likert scale. Scores range from 0-108. Higher scores indicate better quality of life.
Local Pain Control as Measured by Brief Pain Inventory (BPI)
The BPI measures pain intensity and the functional interference caused by pain via four items assessing average, worse, least, and immediate pain intensity in the last 24 hours. Pain intensity is measured using an 11-point numeric rating scale (0=no pain; 10=worst you can imagine). Higher scores indicate greater pain.
Rate of ambulation preservation
The ambulation status is evaluated on a 4 level scale where normal = 0, walking with 1 cane = 1, walking with a walker frame = 2, and walking not possible = 3. Scores of 3 at interval follow-up indicate loss of independent ambulation. The rate of preservation is the proportion of patients with preservation divided by the total number of patients on study. Preservation is determined by comparing baseline ambulatory score to interval follow up score.
Maximum planned target volume (PTV) maximum dose (Dmax)
The planning target volume (PTV) maximum dose (Dmax) is the max dose that is planned for study participants to receive. PTV Dmax will be measured in cubic centimeters.
Mean planned target volume (PTV) Dose Mean (DMean)
The PTV Dose mean (DMean) is the average dose planned to received by participants. PTV DMean will be measured in grays (Gy).
PTV D80
PTV D80 is the dose received by 80% of the targeted area. This is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. PTV D80 will be measured in grays (Gy).
PTV D95
PTV D95 is the dose received by 95% of the treated area. This is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. PTV D95 will be measured in grays (Gy).
Spinal cord Dmax
The spinal cord maximum dose is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. Spinal cord Dmax will be measured in cubic centimeters.
Spinal cord D0.03
The spinal cord (SC) D0.03 is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D0.03 is measured in cubic centimeters.
Spinal cord D0.1
The spinal cord (SC) D0.1 is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D0.1 is measured in cubic centimeters.
Spinal cord D1
The spinal cord (SC) D1 is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D1 is measured in cubic centimeters.
Spinal cord D50
The spinal cord D50% is the half maximal inhibitory dose recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D50% is measured in grays (Gy).
Area under the curve (AUC) for receiving operating characteristic analysis
The area under the curve (AUC) is used for receiving operating characteristic analysis to build models predictive of clinical outcomes, incorporating baseline demographics, clinical and laboratory data and radionics features. The target AUC is greater than or equal to 0.80.
Dice's coefficient
Dice's coefficient is use to train machine learning algorithm using MRIdian images to automatically segment tumor, spinal cord, and normal structures in order to improve workflow efficiency of MRI-linac adaptive planning for treatment of protocol disease. The target coefficient is greater than or equal to 0.80.

Full Information

First Posted
October 4, 2023
Last Updated
October 19, 2023
Sponsor
University of Miami
Collaborators
Viewray Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06077071
Brief Title
MRIdian "RADAR" Trial
Official Title
MRIdian "RADAR" Trial - Radiosurgical Debulking of Asymptomatic/Radiographic Spinal Cord Compression Using Stereotactic MRI-guided Adaptive Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Viewray Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to see if treating cancer with the magnetic resonance imaging guided adaptive radiotherapy (MRIdian) can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Epidural Spinal Cord Compression, Spinal Cord Compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ViewRay MRidian
Arm Type
Experimental
Arm Description
Participants will receive five (5) doses of radiation therapy over four (4) weeks. The first dose will be given during week 1; after at least 36 hours from the first dose, participants will receive the second dose. The remaining doses will be three (3) doses will be administered once per week during weeks 2, 3, and 4. The treatment plan may change at the discretion of the treating physician. Participants will have three additional doses each week in Weeks 2, 3, and 4.
Intervention Type
Radiation
Intervention Name(s)
ViewRay MRIdian Stereotactic Radiosurgery
Intervention Description
Participants will undergo stereotactic radiosurgery of the spinal cord on the ViewRay MRIdian, a hybrid MRI-linac platform, with 40 Gy in 5 fractions prescribed to the planning target volume (PTV).
Primary Outcome Measure Information:
Title
One-year failure rate
Description
The one-year failure rate is determined by the number of study participants with clinical failure, defined as needing decompressive surgery at the targeted spinal area due to progression of disease. The rate is determined by the amount of participants with documented clinical failure at any time within ten months of completing protocol therapy. This number is compared to the rate of decompressive surgery in the general population.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Rate of radiation myelopathy
Description
The rate of radiation myelopathy will assess the proportion of patients with neurologic deterioration prior to starting protocol therapy to six months after completing protocol therapy. This is determined using the modified McKenzie scores and will be scored by the treating physician. Scores are A: no abnormality, B: focal minor symptom (e.g. pain), C: functional paresis, D: nonfunctional paresis, and E: paralysis or incontinence. The treating physician will determine if scores are probably or definitely related to protocol therapy and not to local progression of tumor.
Time Frame
Up to 6 months
Title
Rate of vertebral compression fracture
Description
The rate of vertebral compression fracture (VCF) is determined by the number of participants who develop VCF possibly, probably, or definitely related to the protocol therapy, as opposed to tumor progression. This is assessed and determined by the treating physician by reviewing the initial MRI done prior to starting protocol therapy compared to MRI scans done at follow up visits after receiving protocol therapy.
Time Frame
Up to 2 years
Title
Number of Treatment Related Adverse Events as Measured By CTCAE v.5
Description
The number of treatment-related adverse events during the study will be assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5 within 3 months of completing the protocol therapy that are determined to be grades 2 or higher (acute toxicity) by the treating physician.
Time Frame
Up to 1 year
Title
Local control (LC) rate
Description
The local control (LC) is defined as the absence of progression of the disease at the treated spinal area. The LC rate is assessed by comparing two separate MRI scans - the initial MRI done prior to starting therapy compared to the MRI done one month after completing protocol therapy. The rate is determined by assessing progression of disease between the two MRI scans.
Time Frame
Up to 10 weeks
Title
Local progression (LP) rate
Description
The local progression (LP) is defined as the unequivocal increase in tumor volume or linear dimension, any new or progressive tumor within the treated area; or neurological deterioration attributable to pre-existing epidural disease with equivocal increased epidural disease dimensions. The LP rate is assessed by comparing two separate MRI scans - the initial MRI done prior to starting therapy compared to the MRI done one month after completing protocol therapy.
Time Frame
Up to 10 weeks
Title
Change in mean relative in epidural tumor
Description
The mean relative epidural tumor reduction measures the tumor size assessed on the initial MRI scan done prior to starting protocol therapy compared to the tumor size assessed on MRI scan done one month after completing protocol therapy.
Time Frame
Baseline, Up to 10 weeks
Title
Overall epidural tumor response rate
Description
The overall epidural tumor response rate is determined by the objective response rate (ORR) which is defined by the number of participants with objective response to protocol therapy compared to overall number of study participants. This rate is determined based on review of two MRI scans - the initial MRI scan done prior to starting protocol therapy compared to the MRI scan done one month after completing protocol therapy.
Time Frame
Up to 10 weeks
Title
Change in mean relative thecal sac patency
Description
The change in mean relative thecal sac patency is defined as [(postradiosurgery thecal sac area minus preradiosurgery thecal sac area) divided by pre radiosurgery thecal sac area].
Time Frame
Baseline, Up to 10 weeks
Title
Change in thecal sac decompression rate
Description
The change in thecal sac decompression rate is defined as the number of study participants who experienced a relative improvement of thecal sac patency at 1 month post-radiotherapy (post-RT) MRI divided by the total number of study participants.
Time Frame
Baseline, Up to 14 weeks
Title
In-field progression (IFP) rate
Description
The in-field progression (IFP) rate is defined as the proportion of patients with in-field progression, where IFP is defined as the increase in tumor size, any new or progressive tumor within the treatment area, or neurological deterioration attributable to preexisting disease in treatment area. This is determined based on review of two MRI scans - the initial MRI scan done prior to starting protocol therapy compared to the MRI done one month after completing protocol therapy.
Time Frame
Up to 1 year
Title
Distant progression (DP) rate
Description
The distant progression (DP) rate is defined as the proportion of patients who experience DP, where DP is defined as the increase in tumor size or any new or progressive tumor outside of the treatment area.
Time Frame
Up to 1 year
Title
Failure-Free Survival (FFS)
Description
The failure-free survival (FFS) is defined as the time from study enrollment to the first documented clinical failure or death from any cause, whichever occurs first.
Time Frame
Up to 2 years
Title
Overall Survival (OS)
Description
The overall survival (OS) is defined as the time from study enrollment to the time of first documented death from any cause.
Time Frame
Up to 2 years
Title
Quality of Life Assessed Using EuroQol (EQ) Five Dimension (5D) Five Level (5L) (EQ-5D-5L)
Description
The EQ-5D-5L represents a global quality of life measure that includes multiple components. The EQ-5D-5L score includes questions on mobility, self-care, usual activities, anxiety/depression, and pain/discomfort on a 5-point scale: 1=No Problem, 2=Slight Problem, 3=Moderate Problem, 4=Severe Problem, 5=Extreme Problem or Inability. 0, 1, and negative values correspond to death, full health, and health states worse than death, respectively. Higher scores indicate greater levels of problems across each of the five dimensions.
Time Frame
Up to 2 years
Title
Quality of Life Assessed Using FACT-G
Description
Defined by the Functional Assessment of Cancer Therapy General (FACT-G), a 27-item questionnaire designed to measure four domains of health-related QOL in cancer participants. Items are rated on a 5-item Likert scale. Scores range from 0-108. Higher scores indicate better quality of life.
Time Frame
Up 2 years
Title
Local Pain Control as Measured by Brief Pain Inventory (BPI)
Description
The BPI measures pain intensity and the functional interference caused by pain via four items assessing average, worse, least, and immediate pain intensity in the last 24 hours. Pain intensity is measured using an 11-point numeric rating scale (0=no pain; 10=worst you can imagine). Higher scores indicate greater pain.
Time Frame
Up to 2 years
Title
Rate of ambulation preservation
Description
The ambulation status is evaluated on a 4 level scale where normal = 0, walking with 1 cane = 1, walking with a walker frame = 2, and walking not possible = 3. Scores of 3 at interval follow-up indicate loss of independent ambulation. The rate of preservation is the proportion of patients with preservation divided by the total number of patients on study. Preservation is determined by comparing baseline ambulatory score to interval follow up score.
Time Frame
Up to 2 years
Title
Maximum planned target volume (PTV) maximum dose (Dmax)
Description
The planning target volume (PTV) maximum dose (Dmax) is the max dose that is planned for study participants to receive. PTV Dmax will be measured in cubic centimeters.
Time Frame
Up to 1 year
Title
Mean planned target volume (PTV) Dose Mean (DMean)
Description
The PTV Dose mean (DMean) is the average dose planned to received by participants. PTV DMean will be measured in grays (Gy).
Time Frame
Up to 1 year
Title
PTV D80
Description
PTV D80 is the dose received by 80% of the targeted area. This is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. PTV D80 will be measured in grays (Gy).
Time Frame
Up to 1 year
Title
PTV D95
Description
PTV D95 is the dose received by 95% of the treated area. This is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. PTV D95 will be measured in grays (Gy).
Time Frame
Up to 1 year
Title
Spinal cord Dmax
Description
The spinal cord maximum dose is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. Spinal cord Dmax will be measured in cubic centimeters.
Time Frame
Up to 1 year
Title
Spinal cord D0.03
Description
The spinal cord (SC) D0.03 is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D0.03 is measured in cubic centimeters.
Time Frame
Up to 1 year
Title
Spinal cord D0.1
Description
The spinal cord (SC) D0.1 is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D0.1 is measured in cubic centimeters.
Time Frame
Up to 1 year
Title
Spinal cord D1
Description
The spinal cord (SC) D1 is recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D1 is measured in cubic centimeters.
Time Frame
Up to 1 year
Title
Spinal cord D50
Description
The spinal cord D50% is the half maximal inhibitory dose recorded for initial and subsequent radiotherapy plans to verify the advantages of planning and modifying dose levels as needed. D50% is measured in grays (Gy).
Time Frame
Up to 1 year
Title
Area under the curve (AUC) for receiving operating characteristic analysis
Description
The area under the curve (AUC) is used for receiving operating characteristic analysis to build models predictive of clinical outcomes, incorporating baseline demographics, clinical and laboratory data and radionics features. The target AUC is greater than or equal to 0.80.
Time Frame
Up to 1 year
Title
Dice's coefficient
Description
Dice's coefficient is use to train machine learning algorithm using MRIdian images to automatically segment tumor, spinal cord, and normal structures in order to improve workflow efficiency of MRI-linac adaptive planning for treatment of protocol disease. The target coefficient is greater than or equal to 0.80.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female participants ages ≥ 18. Solid tumors causing MESCC for which surgery is an option as first-line treatment. Tumor histologies eligible for treatment include breast, prostate, sarcoma, melanoma, gastrointestinal types, NSCLC and renal cancers. Other solid malignancy types are also allowed at discretion of investigator if not specifically excluded by criteria. MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement. Bilsky scale ≥ 1c MESCC with tumor ≤ 1 mm from the spinal cord or cauda equina nerve roots anywhere from C1 to terminus of cauda equina on screening MRI. Protocol defined MESCC must involve no more than 3 contiguous vertebral levels. MESCC can involve multiple non-contiguous spinal canal regions within those 3 contiguous vertebral levels. Karnofsky performance score ≥60 Survival prognosis ≥3 months Medical status allowing surgery. Neurologic exam within 1 week prior to registration and again within 1 week of first treatment to rule out severe neurologic deficits caused by disease at site of cord compression. Patients with mild to moderate cord neurologic signs are eligible if they are improved or stabilized by steroid. These neurologic signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity 4/5 (lower extremity for ambulation or upper extremity for raising arms and/or arm function). All patients must be ambulatory. Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment) Spine instability neoplastic score < 14 a. An exception to this criterion may be made if the patient is evaluated by a spinal surgeon and the surgeon defers surgery. Willing and able to undergo daily MRI during treatment Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 History and physical within 2 weeks prior to registration Patients must provide study specific informed consent prior to study entry. Exclusion Criteria: Unknown primary histology Patients with rapid neurologic decline. Bony retropulsion causing neurologic abnormality Non-ambulatory patients. Prior radiation to the involved site. Inability to have an MRI Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases) Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma) Patients with impaired decision-making capacity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Spieler, MD
Phone
305-243-4229
Email
bxs737@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Spieler, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Spieler, MD
Phone
305-243-4229
Email
bxs737@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Benjamin Spieler, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

MRIdian "RADAR" Trial

We'll reach out to this number within 24 hrs