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

NCT02713269 | Active Not Recruiting Phase 2

• 3 other identifiers: 2015-0223NCI-2016-00683P30CA016672
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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 Lung Non-Small Cell Cancer AJCC v7; Thyroid Gland Carcinoma; Stage IV Breast Cancer AJCC v6 and v7

Outcome Measures

Primary Outcomes (1)

• Local tumor control rate

  Kaplan-Meier estimates will be used.

  At 6 months

Secondary Outcomes (8)

• Local tumor control

  Up to 24 months

• Epidural control assessed by volumetric measurements

  Up to 24 months

• Overall survival

  Up to 24 months

• Changes in symptoms assessed by physical examination

  Baseline to 24 months

• Changes in symptoms assessed by neurological examination

  Baseline to 24 months

Study Arms (1)

Treatment (thermal ablation, SSRS)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Stereotactic Radiosurgery; Procedure: Thermal Ablation Therapy

Interventions

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Treatment (thermal ablation, SSRS)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (thermal ablation, SSRS)

Questionnaire Administration OTHER

Ancillary studies

Treatment (thermal ablation, SSRS)

Stereotactic Radiosurgery RADIATION

Undergo CT-guided SSRS

Also known as: Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Treatment (thermal ablation, SSRS)

Thermal Ablation Therapy PROCEDURE

Undergo thermal ablation therapy

Also known as: thermal ablation

Treatment (thermal ablation, SSRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Carcinoma, Renal Cell; Neoplasms, Unknown Primary; Melanoma; Sarcoma; Spinal Cord Compression; Thyroid Neoplasms

Interventions

Radiosurgery; Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms, Connective and Soft Tissue; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Jing Li

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 18, 2016
• Study Start: August 29, 2016
• Primary Completion (Estimated): October 28, 2027
• Study Completion (Estimated): October 28, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)