N/A
N=24
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Melanoma · Metastatic Malignant Neoplasm in the Spine · Renal Cell Carcinoma · Soft Tissue Sarcoma · Spinal Cord Compression
Bottom Line
View on ClinicalTrials.gov: NCT02527304 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. — 1; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Image-Guided Adaptive Radiation Therapy (Radiation); Quality-of-Life Assessment (Other); Questionnaire Administration (Other); Stereotactic Body Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Albert Einstein College of Medicine
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. |
1; 14 | — |
| PRIMARY Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor |
8; 6 | — |
| SECONDARY Change in Ambulation (Mobility) |
.3 | — |
| SECONDARY Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation |
4.3; 7.18; 3.46; 5.85; 2.85; 6 | — |
| SECONDARY Health Related Quality of Life Scores (FACT-G) |
5 | — |
| SECONDARY Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4 |
— | — |
| SECONDARY Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4 |
— | — |
| SECONDARY Overall Survival |
13 | — |
| SECONDARY Progression-free Survival |
12 | — |
Summary
This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT) in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT uses information gathered during treatment to inform, guide, and alter future radiation treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.
Eligibility Criteria
Inclusion Criteria
- Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging [MRI] or computed tomography [CT] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
- History/physical examination by the treating physician within 24 hours prior to registration
- Neurological and functional examination within 24 hours prior to registration by the treating physician
- Negative serum pregnancy test
- MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
- Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
- Women of childbearing potential must:
- Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
- Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
- Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
- All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
- Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Exclusion Criteria
- Histologies of myeloma or lymphoma
- Cord compression at 2 non-contiguous sites in the spine
- Favorable candidates for surgical decompression by prior documented criteria
- Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score > 12
- > 50% loss of vertebral body height
- Bony retropulsion causing neurologic abnormality
- Prior radiation to the index spine
- Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy, renal failure or other medical contraindication
Data sourced from ClinicalTrials.gov (NCT02527304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.