Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-29

Study Completion Date

2027-10-28

Brief Summary

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This phase II clinical trial studies how well thermal ablation and spine stereotactic radiosurgery work in treating patients with cancer that has spread to the spine (spine metastases) and is at risk for compressing the spinal cord. Thermal ablation uses a laser to heat tumor tissue and helps to shrink the tumor by destroying tumor cells. Stereotactic radiosurgery delivers a large dose of radiation in a short time precisely to the tumor, sparing healthy surrounding tissue. Combining thermal ablation with stereotactic radiosurgery may be a better way to control cancer that has spread to the spine and is at risk for compressing the spinal cord.

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Detailed Description

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PRIMARY OBJECTIVE:

I. To document the rate of local control at 6 months in patients who receive a combination of thermal ablation and stereotactic spine radiosurgery (SSRS) for spine metastases with moderate to severe epidural involvement.

SECONDARY OBJECTIVES:

I. To determine local control at 1, 3, 9, 12, 18, and 24 months, and to compare to a historical control where patients received only SSRS at these time points and at 12 months.

II. To document the extent of epidural tumor regression at 1, 3, 6, 9, 12, 18 and 24 months.

IIa. Calculate decrease in epidural tumor volume (by volumetric measurements). IIb. Calculate increase in thecal sac patency (by volumetric measurements and according to Bilsky method).

III. To determine overall survival at 6, 12, 18, and 24 months. IV. To assess changes in muscle strength, location and severity of spinal-related pain, sensory function, ability to ambulate, and neurological grading at 1, 3, 6, 9, 12, 18, and 24 months compared with pretreatment baselines.

V. To assess the effect of treatment on quality of life (QOL), measured at 1 month and every 3 months after with validated outcome measure tools.

VI. To describe adverse side effects after treatment and to descriptively correlate those effects with radiographic findings, pain control, and quality of life.

OUTLINE:

Patients undergo thermal ablation and computed tomography (CT)-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.

After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months and then every 6 months.

Conditions

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Malignant Digestive System Neoplasm Metastatic Head and Neck Carcinoma Metastatic Kidney Carcinoma Metastatic Malignant Neoplasm in the Spine Metastatic Malignant Neoplasm of Unknown Primary Metastatic Melanoma Prostate Carcinoma Metastatic in the Bone Sarcoma Solid Neoplasm Spinal Cord Compression Stage IV Breast Cancer AJCC v6 and v7 Stage IV Lung Non-Small Cell Cancer AJCC v7 Thyroid Gland Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (thermal ablation, SSRS)

Patients undergo thermal ablation and CT-guided SSRS via intensity-modulated radiation therapy on different dates within a 1-14 day window. The order of treatment is at the doctor's discretion.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT scan

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Stereotactic Radiosurgery

Intervention Type RADIATION

Undergo CT-guided SSRS

Thermal Ablation Therapy

Intervention Type PROCEDURE

Undergo thermal ablation therapy

Interventions

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Computed Tomography

Undergo CT scan

Intervention Type PROCEDURE

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Stereotactic Radiosurgery

Undergo CT-guided SSRS

Intervention Type RADIATION

Thermal Ablation Therapy

Undergo thermal ablation therapy

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computerized Axial Tomography computerized tomography CT CT SCAN tomography Quality of Life Assessment Stereotactic External Beam Irradiation stereotactic external-beam radiation therapy stereotactic radiation therapy Stereotactic Radiotherapy stereotaxic radiation therapy stereotaxic radiosurgery thermal ablation

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age.

Exclusion Criteria

* 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-T12.
* 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.
* 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 participating in this study, she should inform her treating physician immediately.
* Prior conventional radiation to the same site is allowed as long as there is a greater than 3 months interval.
* 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.
* 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:

* 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.
* Prior conventional irradiation of the spine site and level to be treated with an interval shorter than 3 months.
* Lesions located outside of the spinal segments of T2 to T12.
* Prior surgery to the same levels of spine.
* Inability to lie flat on a treatment table for \>60 minutes.
* Unable to undergo MRI of the spine
* Pregnancy (because radiation has the potential for teratogenic or abortifacient effects).
* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No