Phase I Study of Feasibility of Single Session Spine Stereotactic Radiosurgery (SSRS) in the Primary Management in Patients With Inoperable, Previously Unirradiated Metastatic Epidural Spinal Cord Compression (MESCC)
2 other identifiers
interventional
43
1 country
1
Brief Summary
The goal of this clinical study is to learn the feasibility of using a single session of radiation, known as spine stereotactic radiosurgery (SSRS), to treat metastatic epidural spinal cord compression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2010
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2010
CompletedStudy Start
First participant enrolled
December 3, 2010
CompletedFirst Posted
Study publicly available on registry
December 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
April 16, 2026
April 1, 2026
16.3 years
December 3, 2010
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Occurrences of Paralysis caused by Radiation Myelitis (RM)
Incidence of patients who are ambulatory at baseline, 3 months and 6 months will be tabulated. Cases of patients who develop spinal cord myelopathy determined to be radiation related graded according to NCI CTC v4.0 scale.
Up to 12 months following radiation
Study Arms (1)
Stereotactic Radiosurgery (SSRS)
EXPERIMENTALTarget dose of 18 or 24 Gy to spine in single session of radiation treatment.
Interventions
Target dose of 18 or 24 Gy to spine in single session of radiation treatment.
Eligibility Criteria
You may qualify if:
- Greater than or equal to 18 years old
- Radiographically documented metastatic epidural compression on spine Magnetic resonance imaging (MRI) within 4 weeks of registration, defined radiographically, ranging from minimal canal compromise and thecal indentation to actual displacement of the spinal cord.
- Maximum of 3 contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session
- Signed Informed consent
You may not qualify if:
- Motor Strength \>/= 4 out of 5 in extremity or extremities affected by the level of the spinal cord compression
- Karnofsky performance status (KPS) \>/= 40
- Patients deemed to be inoperable by patient refusal, by neurosurgical evaluation, or for any reason
- Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinoma, germ cell tumors) as conventional radiation is likely to be effective
- Prior irradiation of the spine site and level to be treated
- Inability to tolerate lying flat on treatment table for greater than 30 minutes.
- Patients unable to undergo MRI of the spine
- Patients who are pregnant
- Patients who have cord compression from bone components or configuration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amol J. Ghia, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2010
First Posted
December 7, 2010
Study Start
December 3, 2010
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
April 16, 2026
Record last verified: 2026-04