Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases (NCT05023772) | Clinical Trial Compass
RecruitingNot Applicable
Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases
United States60 participantsStarted 2021-09-02
Plain-language summary
The purpose of this research is to combine two complementary modes of treatment, spinal interstitial laser ablation and stereotactic spine radiosurgery (SSRS) for the treatment for spinal tumors near the spinal cord with an objective to improve tumor control, improve pain control, preserve function, and improve quality of life. We will also assess how effective these combined modes of treatment are in patients with spinal metastasis with an epidural component.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age \> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)
* 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.
* 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.
* The vertebral body site to be treated must be located from T2 to L1
* No more than 3 contiguous or dis-contiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or 3 sessions.
* 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).
* ECOG performance status \<2 or Karnofsky performance status (KPS) \>50
* Life expectancy \>3 months.
* Inoperable disease because of patient refusal, neurosurgical evaluation, or any other medical reasons.
* 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 part…