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Radiation Therapy

Radiation Therapy 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 1 prior course of spine radiotherapy to the current region of interest allowed.

Maximum of 2 metastatic sites in the spine to be irradiated over a single course of treatment

Must not have

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

Worsening neurological status due to radiographic evidence of spinal cord compression requiring immediate surgical decompression or emergent conventional external radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3, 6, 9, 12, 18, and 24 months, then every six months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if a cancer treatment is safe and effective for treating tumors in the spine. The side effects and feasibility of the treatment will also be looked at.

Who is the study for?

This trial is for individuals with metastatic spine tumors from various cancers, including lung and breast cancer. Participants must have a Karnofsky performance status of at least 40, can have had one prior spine radiotherapy, and up to two spinal metastatic sites. Exclusions include recent chemotherapy, inability to undergo MRI or lie flat for treatment duration, previous maximum radiation dose received, unstable spine needing surgery, pacemaker presence or immediate need for surgical decompression.

What is being tested?

The study evaluates the safety and effectiveness of stereotactic spine radiotherapy (SSRS) using CT-on-rails in treating spinal tumors. It will assess the precision of this technology and document any side effects experienced by participants during treatment.

What are the potential side effects?

Potential side effects may include typical reactions to radiation therapy such as skin irritation at the treatment site, fatigue, nausea, potential worsening of neurological symptoms if existing conditions are aggravated by the treatment process.

Eligibility Criteria

Inclusion Criteria

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

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I have had only one spine radiotherapy session in the affected area.

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I have up to 2 cancer spots in my spine needing radiation.

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

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My cancer type is among those listed, such as lung, breast, or melanoma.

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

Exclusion Criteria

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

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I have not had chemotherapy in the last 30 days.

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

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My spine needs surgery to be stabilized.

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

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I cannot lie flat for more than 30 minutes.

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I have not been re-treated with radiation under this protocol before.

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I have received the maximum safe radiation dose to my spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3, 6, 9, 12, 18, and 24 months, then every six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3, 6, 9, 12, 18, and 24 months, then every six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3, 6, 9, 12, 18, and 24 months, then every six 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

Pain

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: Radiation TherapyExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 12Eligibility criteria met