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

Primary Purpose

Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma, Metastatic Kidney Carcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Computed Tomography

Quality-of-Life Assessment

Questionnaire Administration

Stereotactic Radiosurgery

Thermal Ablation Therapy

About this trial

This is an interventional treatment trial for Malignant Digestive System Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 </=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).

Sites / Locations

M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (thermal ablation, SSRS)

Arm 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.

Outcomes

Primary Outcome Measures

Local tumor control rate

Kaplan-Meier estimates will be used.

Secondary Outcome Measures

Local tumor control

Kaplan-Meier estimates will be used. Time to local failure will be monitored continuously using a Bayesian method. Cumulative incidence of local failure will be estimated failure treating death without failure as a competing risk. Propensity score analyses will be used to compare the thermal ablation cohort with a historical cohort where patients received only stereotactic spine radiosurgery (SSRS).

Epidural control assessed by volumetric measurements

Extent of epidural tumor regression be determined by change in epidermal tumor volume and change in thecal sac patency (by volumetric measurements and according to Bilsky method). Kaplan-Meier estimates will be used. Cumulative incidence of epidural failure will be estimated failure treating death without failure as a competing risk. Propensity score analyses will be used to compare the thermal ablation cohort with a historical cohort.

Overall survival

Kaplan-Meier estimates will be used.

Changes in symptoms assessed by physical examination

The Physical exam includes general exam, (HEENT) Head, Eye, Ear, Nose and Throat evaluation, chest, heart, abdomen and extremities exam. Combined with the neurotically examination results, changes at 1, 3, 6, 9, 12, 18, and 24 months will be compared with pretreatment baselines. Patients with negative changes will be evaluated by the neurosurgeon and radiation oncologist to determine if the change is related to a local failure/complication or to progression of systemic disease. Kaplan-Meier estimates will be used.

Changes in symptoms assessed by neurological examination

The neurological exam includes (1) mental status (tested through history taking), (2) cranial nerves (Observation of eyes, face, voice, and coordination during history taking and as patient moves about the exam room. Look for extraneous movements), (3) motor system (visual inspection, tone, muscle strength and endurance, assigned score of 0-5 for each muscle, a score of 0 would mean no muscular contraction, and a score of 5 would mean movement against full resistance, normal strength), (4) reflexes, (5) sensory system (vibration in toes; pinprick in feet; (6) coordination (Truncal stability, fine finger movement, toe tapping, finger-nose-finger, heel-knee-shin), and (7) station and gait (Gait including arising from chair without hands, walking on toes, heels, and heel to toe). Kaplan-Meier estimates will be used.

Changes in quality of life (QOL) assessed by the MD Anderson Symptom Inventory Spine Tumor form

Participants are asked to recall symptom severity and interference during the past 24 hours. Part I, The severity of the symptoms, including pain, fatigue, nausea, disturbed sleep, short of breath etc. Part II, How have the symptoms interfered with patient life, including mood, work, relations with other people etc. Part I, range 0-10. A score of 0 would mean the symptom is not present and a score of 10 means the symptom is as bad as you can imagine). Part II, range 0-10 (A score of 0 would mean the symptom did not interfere; A score of 10 means the symptom has interfered completely).

Changes in quality of life (QOL) assessed by Brief pain inventory (BPI) form

Participants are asked to assess the severity of pain and the impact of pain on daily functions. Severity of pain, including the pain location, worst pain in last 24 hours, least pain in last 24 hours, pain on average and pain right now. Range 0-10. A score of 0 would mean no pain and a score of 10 means the pain is as bad as you can imagine. Pain medications, amount of pain relief in the past 24 hours, and impact of pain on daily function, including general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life, and Range 0-10.

Changes in quality of life (QOL) assessed by SF-12 healthy survey (v2)

Participants are asked to twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH). 3 and 5 point Likert scale is used in the survey. Two summary scores of the SF-12v2-physical and mental health-using the weighted means of the eight domains. Descriptive statistics will be used to summarize pain relief and quality of life at each follow-up visit, which will be the changes in scores from baseline to each assessment visit. Time to maximum pain relief will be the time from the day of thermal ablation until the lowest pain score for average pain after radiotherapy.

Full Information

NCT ID

NCT02713269

First Posted

March 15, 2016

Last Updated

October 3, 2023

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02713269

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

August 29, 2016 (Actual)

Primary Completion Date

September 26, 2023 (Actual)

Study Completion Date

September 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (thermal ablation, SSRS)

Arm Type

Experimental

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Computed Tomography

Other Intervention Name(s)

CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Intervention Description

Undergo CT scan

Intervention Type

Other

Intervention Name(s)

Quality-of-Life Assessment

Other Intervention Name(s)

Quality of Life Assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Radiation

Intervention Name(s)

Stereotactic Radiosurgery

Other Intervention Name(s)

Stereotactic External Beam Irradiation, stereotactic external-beam radiation therapy, stereotactic radiation therapy, Stereotactic Radiotherapy, stereotaxic radiation therapy, stereotaxic radiosurgery

Intervention Description

Undergo CT-guided SSRS

Intervention Type

Procedure

Intervention Name(s)

Thermal Ablation Therapy

Other Intervention Name(s)

thermal ablation

Intervention Description

Undergo thermal ablation therapy

Primary Outcome Measure Information:

Title

Local tumor control rate

Description

Kaplan-Meier estimates will be used.

Time Frame

At 6 months

Secondary Outcome Measure Information:

Title

Local tumor control

Description

Time Frame

Up to 24 months

Title

Epidural control assessed by volumetric measurements

Description

Time Frame

Up to 24 months

Title

Overall survival

Description

Kaplan-Meier estimates will be used.

Time Frame

Up to 24 months

Title

Changes in symptoms assessed by physical examination

Description

Time Frame

Baseline to 24 months

Title

Changes in symptoms assessed by neurological examination

Description

Time Frame

Baseline to 24 months

Title

Changes in quality of life (QOL) assessed by the MD Anderson Symptom Inventory Spine Tumor form

Description

Time Frame

Baseline to 24 months

Title

Changes in quality of life (QOL) assessed by Brief pain inventory (BPI) form

Description

Time Frame

Baseline to 24 months

Title

Changes in quality of life (QOL) assessed by SF-12 healthy survey (v2)

Description

Time Frame

Baseline to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 </=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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jing Li

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

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