Bronx, New York 10461


Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval treatment response in patients with metastatic epidural spinal cord compression (MESCC), such that additional stereotactic radiotherapy to full therapeutic doses can be delivered while respecting spinal cord constraints, based on the following metrics: shortest distance between gross disease and the spinal cord before and after treatment; epidural tumor volume before and after treatment; and extent of epidural compression before and after treatment. SECONDARY OBJECTIVES: I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after treatment. II. To evaluate patient quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) before and after treatment. III. To evaluate functional outcomes using ambulation score and standardized neurologic exams before and after treatment. OUTLINE: Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. After completion of study treatment, patients are followed up periodically.


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


NCT ID:

NCT02527304


Primary Contact:

Principal Investigator
Madhur Garg
Albert Einstein College of Medicine of Yeshiva University


Backup Contact:

N/A


Location Contact:

Bronx, New York 10461
United States

Madhur K. Garg
Phone: 718-920-4361
Email: mgarg@montefiore.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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