Thermal Ablation and Stereotactic Spine Radiosurgery (SSRS)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/18/2019
Start Date:August 2016
End Date:August 2022
Contact:Jing Li, MD
Phone:713-563-2300

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A Phase II Clinical Trial Evaluating the Efficacy of Combining Thermal Ablation and Spine Stereotactic Radiosurgery for Patients With Spine Metastases With Moderate to Severe Epidural Involvement

The goal of this clinical research study is to find out if combining thermal ablation (using
a laser to heat tumor tissue in order to shrink the tumor size) and spine stereotactic
radiosurgery (SSRS--a method for giving radiation) can help control cancer that has spread to
the spine.

This is an investigational study. Thermal ablation is FDA approved for treatment of soft
tissue tumors. SSRS is delivered using established and commercially available methods, to
patients with cancer that has spread to the spine. The combination of thermal ablation and
SSRS to treat cancer that has spread to the spine with tumor in the spinal canal is
investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.


Inclusion Criteria:

1. At least 18 years of age.

2. Histologic diagnosis of solid malignant tumor (not one of the more radiosensitive
histologic subtypes, see Exclusion Criteria), including but not limited to non-small
cell lung cancer, breast, prostate, renal cell, melanoma, gastrointestinal, sarcoma,
thyroid, head and neck primary, and unknown primary tumors.

3. Quantification of the degree of epidural spinal cord compression as grade 1C, 2, or 3
by MRI, with and without contrast sequences. Axial T2 sequence is encouraged but not
required.

4. The vertebral body site to be treated must be located from T2-T12.

5. No more than 3 contiguous or discontiguous vertebral levels involved with metastasis
in the spine to be irradiated in a single session or 3 sessions.

6. Motor strength >/=4 out of 5 in extremity or extremities affected by the level of the
spinal cord compression (see section 4 for grading method).

7. ECOG performance status /=50

8. Life expectancy >3 months.

9. Inoperable disease because of patient refusal, neurosurgical evaluation, or any other
medical reasons.

10. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) before study entry and for
the duration of study participation. Should a woman become pregnant or suspect she is
pregnant while she or her partner is participating in this study, she should inform
her treating physician immediately.

11. Prior conventional radiation to the same site is allowed as long as there is a greater
than 3 months interval.

12. All patients must sign informed consent forms verifying that they are aware of the
investigational nature of this study in keeping with the rules and policies of MD
Anderson Cancer Center. The only acceptable consent form is one approved by the MD
Anderson institutional review board.

13. Patients who do not have other options of treatment, based on consensus recommendation
of the multidisciplinary spine SRS (SSRS) tumor board. Patients will have an
appropriate medical oncologist for their disease.

Exclusion Criteria:

1. Primary tumors of radiosensitive histology (lymphoma, multiple myeloma, small cell
carcinoma, germ cell tumors), as conventional radiation is likely to be effective in
such cases.

2. Prior conventional irradiation of the spine site and level to be treated with an
interval shorter than 3 months.

3. Lesions located outside of the spinal segments of T2 to T12.

4. Prior surgery to the same levels of spine.

5. Inability to lie flat on a treatment table for >60 minutes.

6. Unable to undergo MRI of the spine

7. Pregnancy (because radiation has the potential for teratogenic or abortifacient
effects).

8. Frank cord compression or cord compression from bone components or configuration and
acute neurological deficits (defined as motor strength <4/5 in extremity or
extremities affected by the level of the spinal cord compression).
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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from
Houston, TX
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