Metastatic Epidural Spinal Cord Compression, Spinal Cord Compression
Conditions
Brief summary
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).
Interventions
RADIATIONStereotactic Radiosurgery (SRS)
The 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.
Sponsors
University of Miami
Varian Medical Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants ages ≥ 18. 2. Solid tumors causing Metastatic epidural spinal cord compression (MESCC) for which surgery is an option as first-line treatment. 3. 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. 4. MRI of involved spine within 4 weeks prior to registration to determine extent of spine involvement. 5. 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. 6. 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. 7. Karnofsky performance score ≥60 8. Survival prognosis ≥3 months 9. Medical status allowing surgery. 10. 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. 11. 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). 12. All patients must be ambulatory. 13. Numerical Rating Pain Scale within 1 week prior to registration (back pain permitted for enrollment). 14. 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. 15. Willing and able to undergo daily MRI during treatment. 16. Willingness and able to use an acceptable method of contraception during the study and for at least 6 months after stopping the therapy. 17. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2. 18. History and physical within 2 weeks prior to registration. 19. Patients must provide study specific informed consent prior to study entry.
Exclusion criteria
1. Unknown primary histology. 2. Patients with rapid neurologic decline. 3. Bony retropulsion causing neurologic abnormality. 4. Non-ambulatory patients. 5. Prior radiation to the involved site. 6. Inability to have an MRI. 7. Pre-existing or concomitant neurological problems not related directly to MESCC (e. g., neurologic deficits due to brain metastases). 8. Very radiosensitive tumor histology (e.g., myeloma, seminoma, germ cell tumors, leukemia, and lymphoma). 9. Patients with impaired decision-making capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Safe Avoidance of Surgery | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Confidence in Ethos Virtual Magnetic Resonance (MR) Workflow | Day 1 of Treatment, Up to 4 weeks | 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. |
| Rate of Radiation Myelopathy (RM) | Baseline, Up to 8 months | 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. |
| Rate of Vertebral Compression Fracture (VCF) | Up to 2 years | 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 Participants Experiencing Grade 2 or Higher Treatment-Related Adverse Events | Up to 12 months | 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). |
| Quality of Life Among Study As Measured by Scores on PROMIS Short Form Version 1.0 | Baseline, Up to 6 months | Quality of life among participants will be measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form version 1.0. PROMIS Short Form version 1.0 consists of targeted, fixed-length questionnaires derived from National Institute of Health (NIH) item banks to measure physical, mental, and social health domains. Scores use a T-score metric standardized to a mean of 50 and standard deviation of 10 relative to the general population. PROMIS Short Form version 1.0 scores will be measured at baseline, 1 month, 3 months and 6 months after protocol enrollment. |
| Rate of Ambulation Preservation | Up to 2 years | Ambulation status among participants will be evaluated on a four-level scale where a score of 0 = normal, 1 = walking with one cane, 2 = walking with a walker frame, and 3 = walking not possible. Scores of 3 at interval follow-up indicate loss of independent ambulation. The rate of ambulation preservation is the number 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. |
Countries
United States
Contacts
CONTACTBenjamin Spieler, MD
PRINCIPAL_INVESTIGATORBenjamin Spieler, MD
University of Miami
Outcome results
None listed