Evaluation of Single Session Stereotactic Body Radiotherapy

March 6, 2024 updated by: M.D. Anderson Cancer Center

Phase I/II Evaluation of Single Session Stereotactic Body Radiotherapy for Spinal or Paraspinal Metastases

The goal of this clinical research study is to find out if stereotactic body radiotherapy to the spine using computerized tomography (CT)-on-Rails is safe and effective in the treatment of metastatic spine tumors.

Objectives:

  • Establish the safety and efficacy of using stereotactic body radiotherapy (SBRT) to treat spine and para-spinal tumors in a single session.
  • Document frequency and severity of pain, symptoms and symptom interference, as well as quality of life before and after treatment.
  • Document changes in neurological function at defined intervals compared to pre-treatment neurological function.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

CT-on-Rails 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 before registration on this study. You will also fill out a health survey, a symptom inventory, and a Brief Pain Inventory within 1 week before registration. Each of these surveys should take about 5 minutes to complete. You will have a CT-simulation. The simulation is like a CT scan where a special body frame is used to keep you from moving during scanning and later radiation treatment. However, no radiation is delivered during the simulation. You will be asked questions about your medical history and have a complete neurological exam during your first consultation, before registration. The neurological exam involves testing upper and lower motor strength, sensation to light touch, reflexes, a mental exam, and an evaluation of the way you walk.

Radiation treatment will last between 2 and 2 1/2 hours and will be given on 1 day about 1 to 1 1/2 weeks after you had the simulation. You will have a device (similar to plastic wrap) placed around you that will hold you still during the treatment. You will be checked for level of pain and/or discomfort before starting each session of radiation, and you may take pain medications before starting each session. All participants will be treated with radiation therapy that is guided by the CT-on-Rails procedure. On the day of radiation, you will also receive a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment.

During treatment, a physician will be monitoring you for any side effects. If you experience severe side effects, radiation treatment will be stopped, and you will be taken off study. After treatment on this study ends, you will have telephone, mail, or facsimile (Fax) follow-ups scheduled at 1, 2, 3, 4, and 8 weeks after radiation. You will be asked questions about any side effects or pain you are experiencing and any other therapies you may have started.

You will have follow-up visits scheduled at 3, 6, 9, 12, 18, and 24 months and then every 6 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 your neurologic function will be evaluated. Any pain medication you are taking will be noted. You will be asked to have a 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, pain, and quality of life at each follow-up visit. Each questionnaire should take around 5 minutes to complete.

This is an investigational study. The equipment used in this study are FDA-approved medical devices and are commercially available. However, the way the devices are being used in this study is experimental. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Interventional

Enrollment (Actual)

71

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 weeks of registration
  2. Maximum of 2 metastatic sites in the spine to be irradiated in single session
  3. Informed consent for irradiation of spinal or para-spinal tumor (s)
  4. Diagnosis of cancer including but not limited to lung (non-small cell and small cell), breast, prostate, renal cell, melanoma, gastrointestinal, and germ cell tumors, unknown primary tumors
  5. Karnofsky performance status of at least 40 (ie not requiring active hospitalization)

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. Prior irradiation to current site of interest in the spine
  4. Spinal metastasis in the cervical spine are not eligible for treatment
  5. Unstable spine requiring surgical stabilization.
  6. Sites outside the spine (eg. lung, liver) are not eligible for treatment
  7. Patients currently receiving, or who have received chemotherapy within 30 days are not eligible
  8. Inability to tolerate lying flat on treatment couch for greater than 30 minutes.
  9. Patient with multiple myeloma
  10. Patients unable to undergo MRI of the spine
  11. Patients with pacemakers

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: Single Session Stereotactic Body Radiotherapy (SBRT)
On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
Procedure: Stereotactic Body Radiotherapy
On day 1 of radiation treatment, a CT scan using CT-on-Rails in the same treatment room, immediately before the radiation treatment will be performed.
Other Names:
  • SBRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and para-Spinal Tumors in a Single Session
Time Frame: 3 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 will be 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.
3 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.

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 1, 2005

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimated)

June 27, 2007

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0445
  • NCI-2012-01499 (Registry Identifier: NCI CTRP- Clinical Trials Reporting Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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