Miami "RADAR" Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami
About this trial
The purpose of this study is to see if treating cancer with radiation therapy administered by the Varian Ethos system can control patient's tumor and eliminate the need for surgery used to treat nerves in the spine flattened by pressure (compressed).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female participants ages ≥ 18.
Solid tumors causing Metastatic epidural spinal cord compression (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.
Disqualifiers
Unknown primary histology.
Patients with rapid neurologic decline.
Bony retropulsion causing neurologic abnormality.
Non-ambulatory patients.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Radiosurgery (SRS)
RadiationThe treatment regimen consists of 8.0 Gy of radiation therapy administered on the Varian Ethos platform, delivered over five (5) fractions prescribed to the planning target volume (PTV) over 4 weeks, with one (1) to two (2) fractions delivered weekly and at least 48 hours between any two fractions.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Stereotactic Radiosurgery (SRS) GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Safe Avoidance of Surgery
The rate of safe avoidance of surgery will be reported as the number of participants experiencing both (1) the absence of local progression at the treated spine level (s), and (2) the absence of surgery at the treated spine level(s) due to disease progression and/or structural instability, after completion of protocol therapy.
Time frame
6 monthsSecondary outcomes
1
Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow
Investigators participating in the protocol, including physicians, physicists, dosimetrists and therapists, will complete an in-house longitudinal usability survey before each treatment session to evaluate the effectiveness, efficiency, satisfaction and learnability of the Ethos virtual magnetic resonance (MR) workflow. An Ethos emulator that allows investigators to evaluate contour and plan generation in advance of treatment delivery will assist in streamlining this process.
Time frame
Day 1 of Treatment, Up to 4 weeks2
Rate of Radiation Myelopathy (RM)
The rate of radiation myelopathy will be reported as the number of participants with change in scores on the Modified McCormick Scale from a baseline score of A, B, or C to post-treatment score of D or E as recorded at interval follow-ups (weekly during radiation therapy, two, three and six months after protocol enrollment). Scores of D or E indicate a higher degree of neurologic deterioration. The treating physician will determine if scores are probably or definitely related to protocol therapy and not to surgery or local progression of tumor. Scores on the Modified McCormick Scale are as follows: A = No abnormality; B = Focal minor symptom (e.g. pain); C = Functional paresis; D = Nonfunctional paresis; and E = Paralysis or incontinence.
Time frame
Baseline, Up to 8 months3
Rate of Vertebral Compression Fracture (VCF)
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 years4
Number of Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events
The number of participants experiencing grade 2 or higher adverse events, probably or definitely related to protocol therapy will be reported. Adverse events will be assessed by the treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
Varian Medical Systems
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: