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Radiation

Single-Session SBRT for Spinal Cancer

Phase 1 & 2

Waitlist Available

Led By Amol J. Ghia, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Maximum of 2 metastatic sites in the spine to be irradiated in single session

Karnofsky performance status of at least 40 (i.e., not requiring active hospitalization)

Must not have

Unstable spine requiring surgical stabilization

Patients currently receiving, or who have received chemotherapy within 30 days are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn if a single session of SBRT to the spine is safe and effective in treating metastatic spine tumors.

Who is the study for?

This trial is for individuals with up to two metastatic spine tumors, confirmed by MRI within the last month. Participants can have various cancer types and must be able to lie flat for treatment without hospitalization (Karnofsky status of at least 40). Exclusions include prior radiation at the site, cervical spine tumors, unstable spines needing surgery, inability to undergo MRI or lie flat for over 30 minutes, pacemakers, urgent spinal cord compression cases, and recent chemotherapy.

What is being tested?

The study tests if a single session of Stereotactic Body Radiotherapy (SBRT) using CT-on-Rails is safe and effective against metastatic spine tumors. It will assess pain levels, symptoms interference with life quality before and after treatment as well as changes in neurological function.

What are the potential side effects?

Potential side effects may include localized pain or discomfort from lying still during treatment; skin reactions similar to sunburn; fatigue; temporary worsening of existing symptoms due to inflammation caused by radiation; rare risk of more serious complications like bone damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have up to 2 cancer spots in my spine that need radiation in one session.

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I do not need to stay in the hospital for my condition.

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I have agreed to radiation treatment for my spinal or near-spinal tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My spine needs surgery to stabilize it.

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I have not had chemotherapy in the last 30 days.

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My cancer has not spread to areas like the lung or liver.

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My cancer has not spread to the bones in my neck.

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I cannot lie flat for more than 30 minutes.

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I need urgent surgery or radiation due to spinal cord pressure shown on scans.

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I have had radiation therapy on the part of my spine that is now of interest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Pain Relief Using Stereotactic Body Radiotherapy (SBRT) to Treat Spine and para-Spinal Tumors in a Single Session

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142

15%

ulcer

10%

vomiting

Perforation

pain

100%

80%

60%

40%

20%

Study treatment Arm

SBRT With Gem

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Session Stereotactic Body Radiotherapy (SBRT)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiotherapy

2017

Completed Phase 2

~220

0 / 10Eligibility criteria met