Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS)

December 12, 2023 updated by: M.D. Anderson Cancer Center

Phase I/II Evaluation of a Novel CT-On-Rails or Trilogy Stereotactic Spine Radiotherapy System (SSRS) for the Treatment of Metastatic Spine Disease

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 a 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 way you walk. 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 is 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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiation Therapy
Radiation 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.
Radiation: Radiation Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Response (Pain Relief)
Time Frame: Baseline, 3, 6, 9, 12, 18, and 24 months, then every six months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Amol J. Ghia, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2002

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

July 27, 2007

First Submitted That Met QC Criteria

July 27, 2007

First Posted (Estimated)

July 30, 2007

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-446 (Other Identifier: MD Anderson)
  • NCI-2012-01584 (Registry Identifier: NCI CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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