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Thermal Ablation and Stereotactic Spine Radiosurgery (SSRS)

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ClinicalTrials.gov Identifier: NCT02713269
Recruitment Status : Recruiting
First Posted : March 18, 2016
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Secondary Malignant Neoplasm of Vertebral Column Spine Metastases Procedure: Thermal Ablation Procedure Radiation: Stereotactic Spine Radiosurgery (SSRS) Behavioral: Symptom Questionnaires Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: Thermal Ablation + Stereotactic Spine Radiosurgery (SSRS)

Participants undergo thermal ablation procedure to tumor tissue using a laser. Radiation treatment starts within 2 weeks of thermal ablation. Treatment delivered in 1 or 3 fractions per treating physician.

Symptom questionnaires completed at baseline and at follow up months 1, 3, 6, 9, 12, then every 6 months.

Procedure: Thermal Ablation Procedure
Thermal ablation procedure performed before spine stereotactic radiosurgery. Thermal ablation heats tumor tissue using a laser, and helps to shrink the tumor by destroying tumor cells.

Radiation: Stereotactic Spine Radiosurgery (SSRS)
Treatment delivered in 1 or 3 fractions per treating physician. One fraction: Gross tumor volume (GTV) prescribed to 24 or 18 Gy in a single fraction depending on the tumor histology. Radioresistant histologies such as renal cell carcinoma, sarcoma and melanoma treated to 24 Gy, and radiosensitive tumor such as breast cancer and non-small lung cancer treated to 18 Gy. Clinical target volume (CTV) prescribed to 16 Gy in a single fraction. Three fractions: GTV prescribed to 24 or 27 Gy in 3 fractions, and the CTV prescribed to 21 Gy in 3 fractions.

Behavioral: Symptom Questionnaires
Symptom questionnaires completed at baseline and at follow up months 1, 3, 6, 9, 12, then every 6 months.
Other Name: Surveys




Primary Outcome Measures :
  1. Rate of Local Tumor Control [ Time Frame: 6 months ]
    Local tumor control assessed by the neuroradiologist based on all available imaging, to include the MRI scans obtained at each follow-up. Tumor volume estimated by measuring the area of enhancement using T1-weighted MRI with gadolinium contrast at the affected level.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 </=2 or Karnofsky performance status (KPS) >/=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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02713269


Contacts
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Contact: Jing Li, MD 713-563-2300

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Medtronic
Investigators
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Principal Investigator: Jing Li, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02713269     History of Changes
Other Study ID Numbers: 2015-0223
NCI-2016-00683 ( Registry Identifier: NCI CTRP )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019

Keywords provided by M.D. Anderson Cancer Center:
Secondary Malignant Neoplasm of Vertebral Column
Spine Metastases
Epidural spinal cord compression
Stereotactic spine radiosurgery
SSRS
Thermal ablation
Symptom questionnaire
Surveys

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Bone Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases