Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease
2 other identifiers
interventional
150
1 country
1
Brief Summary
The goal of this clinical research study is to find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. The feasibility of this type of treatment will be studied as will any side effects related to the treatment. The precision and accuracy of the CT-on-rails will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2002
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
Study Start
First participant enrolled
October 25, 2002
CompletedFirst Submitted
Initial submission to the registry
July 27, 2007
CompletedFirst Posted
Study publicly available on registry
July 30, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
January 15, 2026
January 1, 2026
24 years
July 27, 2007
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Response (Pain Relief)
The validated Brief Pain Inventory (BPI), MD Anderson Symptom Inventory (MDASI), and SF-12v2 Health Survey used to assess changes in these indicators compared to pre-treatment baseline. Response determined by follow-up questionaires. Time to maximal pain relief is the time from the first day of irradiation until the lowest pain score for average pain after radiotherapy. The "worst pain score" from BPI used as the marker for treatment success or failure.
Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months
Study Arms (1)
Radiation Therapy
EXPERIMENTALRadiation Therapy using CT-on-Rails or Trilogy procedure. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
Interventions
Three radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks. Participants prescribed to receive 9 Gy x 3 so that a peripheral dose of 27 Gy is given to the tumor.
Eligibility Criteria
You may qualify if:
- Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 wks of registration
- Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment.
- Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s)
- Diagnosis cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, germ cell tumors, and unknown primary tumors
- Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization)
- Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed.
You may not qualify if:
- Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy
- Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome
- Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment
- Unstable spine requiring surgical stabilization.
- Sites outside the spine (eg. lung, liver) are not eligible for treatment
- Systemic radiotherapy (Sr-89) within 30 days
- Prior irradiation of the area to be treated within 3 months of registration
- Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
- Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
- Patient with multiple myeloma
- Patients unable to undergo MRI of the spine
- Patients with pacemakers
- Patients who have previously received maximum cord tolerance of 45 Gy in 5 weeks conventional fractionation or equivalent dose to the current area to be treated.
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 Publications (2)
Wang XS, Rhines LD, Shiu AS, Yang JN, Selek U, Gning I, Liu P, Allen PK, Azeem SS, Brown PD, Sharp HJ, Weksberg DC, Cleeland CS, Chang EL. Stereotactic body radiation therapy for management of spinal metastases in patients without spinal cord compression: a phase 1-2 trial. Lancet Oncol. 2012 Apr;13(4):395-402. doi: 10.1016/S1470-2045(11)70384-9. Epub 2012 Jan 27.
PMID: 22285199DERIVEDBoehling NS, Grosshans DR, Allen PK, McAleer MF, Burton AW, Azeem S, Rhines LD, Chang EL. Vertebral compression fracture risk after stereotactic body radiotherapy for spinal metastases. J Neurosurg Spine. 2012 Apr;16(4):379-86. doi: 10.3171/2011.11.SPINE116. Epub 2012 Jan 6.
PMID: 22225488DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
July 27, 2007
First Posted
July 30, 2007
Study Start
October 25, 2002
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
January 15, 2026
Record last verified: 2026-01