Study on a New Radiation System for Treating Spine Tumors

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT00508443

Provider View

This clinical trial is testing a new radiation treatment system to see if it is safe and effective for treating spine tumors that have spread from other parts of the body. The study will also look at any side effects and how accurately the treatment can be delivered.

Patient Parameters

Program Overview

The purpose of this study is to find out if a new radiation treatment system, called CT-On-Rails or Trilogy, is safe and effective for treating spine tumors that have spread from other parts of the body. This system uses a CT scanner to help deliver radiation more precisely. Researchers will study how well this treatment works and any side effects it may cause.

Description

In this study, a new radiation treatment system called CT-On-Rails or Trilogy will be used to treat spine tumors. This system places the radiation machine in the same room as a CT scanner, allowing for more precise delivery of radiation.

Before starting treatment, you will have an MRI of your spine and fill out some short surveys about your health and symptoms. A special CT scan will be done to plan your treatment, using a body frame to keep you still.

During your first visit, doctors will ask about your medical history and perform a neurological exam to check your strength, reflexes, and how you walk. You will also complete three short questionnaires about your symptoms and pain.

All patients will receive radiation therapy guided by the CT-On-Rails or Trilogy system. You will have a CT scan right before each treatment, which will be done three times over two weeks.

Doctors will monitor for side effects, especially those affecting the nervous system, digestion, muscles, and blood. If severe side effects occur, treatment will be stopped.

You will have weekly follow-up visits during treatment and regular check-ins by phone or mail after treatment. Follow-up visits will continue for the rest of your life, with MRIs and questionnaires to track your health and symptoms.

This study is investigational, meaning the way the devices are used is new. Up to 150 patients will participate, all at M. D. Anderson.

Eligibility Criteria

Inclusion Criteria

  • Have a spine tumor that has spread from another part of the body, confirmed by an MRI within 4 weeks of joining the study.
  • No more than 2 spine tumor sites to be treated at once.
  • Agree to the treatment and understand the risks.
  • Have a cancer diagnosis, such as lung, breast, prostate, or other types.
  • Be in relatively good health, not needing hospital care.
  • Have had no more than one previous radiation treatment to the spine area being studied.

Exclusion Criteria

  • Worsening neurological symptoms needing immediate surgery or emergency radiation.
  • Delaying radiation could harm neurological health.
  • Already received radiation as part of this study.
  • Unstable spine needing surgery.
  • Tumors outside the spine are not eligible.
  • Received systemic radiation within 30 days.
  • Had radiation to the area within 3 months.
  • Received chemotherapy within 30 days.
  • Cannot lie flat for more than 30 minutes.
  • Have multiple myeloma.
  • Cannot have an MRI.
  • Have a pacemaker.
  • Previously received maximum radiation dose to the spine area.

Locations

FACILITYZIPCITYSTATE
University of Texas MD Anderson Cancer Center77030HoustonTexas

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