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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Local tumor control rate

Secondary Outcome

 Local tumor control

Condition

Malignant Digestive System Neoplasm

Intervention

Computed Tomography

Study Arms / Comparison Groups

 Treatment (thermal ablation, SSRS)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

August 29, 2016

Completion Date

July 1, 2022

Primary Completion Date

July 1, 2022

Eligibility Criteria

        Inclusion:

          -  At least 18 years of age.

          -  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-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 /=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).
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jing Li, 713-563-2300, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02713269

Organization ID

2015-0223

Secondary IDs

NCI-2016-00683

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Jing Li, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

March 2020