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Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, October 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508443
  Purpose

Primary Objectives:

  • Establish the safety and feasibility of using a novel CT-on-Rails or Trilogy stereotactic spine radiotherapy system (SSRS) to treat spine and para-spinal tumors and document any toxicity associated with such treatment
  • Document frequency and duration of complete pain relief, partial pain relief, symptoms, symptom interference, and quality of life related to bone metastases in spine and any associated radicular pain caused by nerve root compression
  • Document changes in neurological function at defined intervals compared to pre-treatment neurological function
  • Establish and quantify the precision and accuracy with which the tumor, spine, spinal cord, and other internal anatomy can be reproduced using a stereotactic body frame

Condition Intervention Phase
Spinal Neoplasms
Radiation: Radiation Therapy
Phase I
Phase II

MedlinePlus related topics: Cancer Spinal Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To find out if stereotactic spine radiotherapy is safe and effective in the treatment of metastatic spine tumors. [ Time Frame: 7 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To study the feasibility of this type of treatment as will any side effects related to the treatment. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
  • To study the precision and accuracy of the CT-on-rails. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2002
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Radiation Therapy using CT-on-Rails or Trilogy procedure
Radiation: Radiation Therapy
Three radiation treatments guided by the CT-on-Rails or Trilogy procedure over a period of 2 weeks.

Detailed Description:

CT-On-Rails or Trilogy is a system that places the radiation treatment machine in the same room as the CT scanner so that the CT scanner can help deliver radiation more precisely.

You will have an MRI of the spine within 1 month of registration on this study. You will also fill out a health survey (5 minutes), a symptom inventory ( 5 minutes), and a Brief Pain Inventory (5 minutes) within 1 week of registration.

A pretreatment feasibility study will first be performed to determine the precision, accuracy, and reproducibility with which the target volume and critical normal structures (e.g. spinal cord) can be positioned relative to the radiation beams for spine tumors; this will consist of a CT scan.

Patients will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep the patient from moving during scanning and later treatment.

You will be asked questions about your medical history and have a complete neurological exam during your first consultation. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, mental exam, and the way you walk. An MRI of the spine must be performed within 1 month of registration. You will be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete, and should be completed within 1 month of being enrolled in the study.

All patients will be treated with radiation therapy that is guided by the CT-on-Rails or Trilogy procedure. Patients will receive a CT scan immediately before the treatment in the same room of the treatment using CT-On-Rails or Trilogy. There will be a total of 3 treatments over a period of 2 weeks.

Monitoring of side effects will be focused on neurological, gastrointestinal, musculoskeletal, and hematological systems. Every attempt will be made to have the patient complete the prescribed course of radiation to maximize the beneficial effect of treatment. However, if there are severe side effects, radiation treatment will be stopped and patients will be taken off study.

You will have follow up visits once a week during radiation treatment, scheduled on the same day as radiation. After treatment, you will have telephone, mail, or follow-ups per fax scheduled at 2 and 4 weeks, and 2 months post radiation. You will have follow up visits scheduled at 3, 6, 9, 12, 18, and 24 months, then every six months for the rest of your life. At all follow-up visits, you will be asked questions about your medical history, have a neurological exam, and neurologic function will be evaluated. Any pain medication you are taking will be noted. You will have an MRI of the spine at 3, 6, 9, 12,18, and 24 months, then once a year for the rest of your life. You will also be asked to complete 3 questionnaires to evaluate your symptoms and pain. Each questionnaire will take around 5 minutes to complete.

This is an investigational study. The CT-on-rails and Trilogy linear accelerator are FDA-approved medical devices and are commercially available, however, the way these two devices are being used is investigational. Up to 150 patients will take part in this study. All will be enrolled at M. D. Anderson.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Radiographically documented spine or paraspinal metastasis demonstrated on spine MRI within 4 wks of registration
  2. Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment.
  3. Informed consent for irradiation or re-irradiation of spinal or para-spinal tumor (s)
  4. Diagnosis of a primary cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell tumor
  5. Karnofsky performance status of at least 40 (i.e. not requiring active hospitalization)
  6. Maximum of 1 prior course of spine radiotherapy to the current region of interest allowed.

Exclusion Criteria:

  1. Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy
  2. Delay in initiation of radiation treatment would be potentially detrimental to neurological outcome
  3. Patients already re-treated with radiation as part of this protocol will not be eligible for additional re-treatment
  4. Unstable spine requiring surgical stabilization
  5. Sites outside the spine (eg. lung, liver) are not eligible for treatment
  6. Systemic radiotherapy (Sr-89) within 30 days
  7. Prior irradiation of the area to be treated within 3 months of registration
  8. Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
  9. Inability to tolerate lying flat on treatment couch for greater than 30 minutes
  10. Patient with multiple myeloma
  11. Patients unable to undergo MRI of the spine
  12. Patients with pacemakers
  13. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508443

Contacts
Contact: Eric L. Chang, MD 713-745-5209

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Eric L. Chang, MD            
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Eric L. Chang, MD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Eric L. Chang, MD/Associate Professor )
Study ID Numbers: ID02-446
Study First Received: July 27, 2007
Last Updated: October 30, 2008
ClinicalTrials.gov Identifier: NCT00508443  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Stereotactic Spine Radiotherapy System
SSRS
CT-on-Rails
Metastatic Spine Disease
Spinal Neoplasms
Radiation Therapy
Trilogy

Study placed in the following topic categories:
Spinal Diseases
Musculoskeletal Diseases
Bone Neoplasms
Bone neoplasms
Bone Diseases
Spinal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009