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Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases

Primary Purpose

Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Management of Therapy Complications
Quality-of-Life Assessment
Questionnaire Administration
Stereotactic Radiosurgery
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Spine

Eligibility Criteria

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

Inclusion Criteria:

  • All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 3 months
  • All patients must be able to lie supine
  • All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated
  • All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gray (Gy)

  • All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics:

    • Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12
    • Pre-existing vertebral body fracture
    • Planned radiation dose of 24 Gy
  • All patients must have a vertebral body site to be treated located from T1 to L5
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to 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
  • All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of M.D. Anderson Cancer Center; the only acceptable consent is the one approved by M.D. Anderson Institutional Review Board (IRB)
  • Patients undergoing bisphosphonate therapy are allowed

Exclusion Criteria:

  • Patients who have had prior radiotherapy at the spine site and level to be treated
  • Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation
  • Patients with gross disease involving only the posterior elements
  • Patients who have > 50% vertebral body collapse
  • Patients unable to undergo magnetic resonance imaging (MRI) of the spine
  • Patents with cord compression
  • Patients deemed not be a candidate for cement augmentation for any reason
  • Patients who have frank mechanical pain
  • Patients with both pedicles involved with gross disease at the level of potential cement augmentation
  • Pregnant women are excluded from this study
  • Patients with a histology of lymphoma, myeloma and small cell lung cancer histologies

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard of care)

Arm II (vertebral body cement augmentation)

Arm Description

Patients undergo stereotactic spinal radiosurgery per standard of care.

Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.

Outcomes

Primary Outcome Measures

Vertebral compression fracture rate
Will compare the 3-month vertebral compression fracture proportions between treatment groups using the Fisher exact test. Will be performed on the intention-to-treat principle.

Secondary Outcome Measures

Time to first new or progressive vertebral body fracture
To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture, will use the Kaplan-Meier method to estimate the freedom from fracture curves and Cox proportional hazards regression analysis to estimate the hazard ratio with confidence intervals and associated p-values.
Pain control, assessed using the Brief Pain Inventory form
Will use mixed effects linear models to analyze this longitudinal data.
Quality of life, assessed using 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. The ratings in the MDASI can be averaged into several subscale scores: mean core symptom severity, mean module symptom severity, mean total symptom severity, and mean interference. The interference items can further be broken down into mean activity interference and mean affective interference. Symptom items may be presented individually
Local control
Will estimate time to first local failure curves using the Kaplan-Meier method.
Overall survival
Will use the Kaplan-Meier method.
Incidence of post-treatment adverse events
Will estimate the difference in grade 3+ toxicity rates, with 95% confidence intervals and a chi-squared test p-value.
Radiographic vertebral body fracture, pain control and quality of life assessment
Will assess the relationship between radiographic vertebral body fracture, pain control and quality of life using correlation analyses. Additional analyses may be conducted as appropriate.
Quality of life, assessed using the EuroQol 5-dimensional 5-level questionnaire.
Will use mixed effects linear models to analyze this longitudinal data. The questionnaire consists 2 parts. Part 1 is descriptive system (participants are asked mobility, self-care status, usual activities, pain/discomfort, anxiety/depression, and each dimension has 5 levels; Part 2 is the Visual analogue scale (the self-rated health today with score 0-100; 100 means the best health you can imagine. 0 means the worst health you can imagine) Part 2, participants give self-rated health today with 100 means the best health you can imagine. 0 means the worst health you can imagine. Part 2, higher range represents a better outcome

Full Information

First Posted
March 9, 2015
Last Updated
May 31, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02387905
Brief Title
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Official Title
Prophylactic Cement Augmentation for Patients at High Risk for Developing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery: A Randomized Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2015 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized phase II trial studies how well cement augmentation works in preventing vertebral body compression fracture following spine stereotactic radiosurgery in patients with solid tumors that have spread to the spine. Spine stereotactic radiosurgery delivers a high dose of radiation to vertebral metastases and can sometimes lead to a vertebral compression fracture. Using body cement on the largest part of the vertebra (a procedure called vertebral body cement augmentation) may help prevent a fracture after stereotactic spinal radiosurgery. It may also lessen pain and improve quality of life in patients with solid tumors and spinal metastases undergoing this surgery.
Detailed Description
PRIMARY OBJECTIVES: I. To assess whether prophylactic cement augmentation reduces new or progressive vertebral body fracture at 3 months in high risk patients undergoing single fraction spine stereotactic radiosurgery. SECONDARY OBJECTIVES: I. To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture. II. To assess the impact of prophylactic cement augmentation on pain control measured every three months post treatment. III. To assess the impact of prophylactic cement augmentation on quality of life measured every three months post treatment. IV. To estimate local control in each arm. V. To estimate overall survival in each arm. VI. To document and assess post-treatment adverse side effects between the two arms. VI. To document and assess the relationship between radiographic vertebral body fracture, pain control and quality of life. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo stereotactic spinal radiosurgery per standard of care. ARM II: Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery. After completion of study treatment, patients are followed up every 3 months for 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard of care)
Arm Type
Active Comparator
Arm Description
Patients undergo stereotactic spinal radiosurgery per standard of care.
Arm Title
Arm II (vertebral body cement augmentation)
Arm Type
Experimental
Arm Description
Patients undergo vertebral body cement augmentation within 4 weeks before or after standard stereotactic spinal radiosurgery.
Intervention Type
Procedure
Intervention Name(s)
Management of Therapy Complications
Intervention Description
Undergo vertebral body cement augmentation
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 standard stereotactic spinal radiosurgery
Primary Outcome Measure Information:
Title
Vertebral compression fracture rate
Description
Will compare the 3-month vertebral compression fracture proportions between treatment groups using the Fisher exact test. Will be performed on the intention-to-treat principle.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Time to first new or progressive vertebral body fracture
Description
To assess the impact of prophylactic cement augmentation on time to first new or progressive vertebral body fracture, will use the Kaplan-Meier method to estimate the freedom from fracture curves and Cox proportional hazards regression analysis to estimate the hazard ratio with confidence intervals and associated p-values.
Time Frame
Up to 2 years
Title
Pain control, assessed using the Brief Pain Inventory form
Description
Will use mixed effects linear models to analyze this longitudinal data.
Time Frame
Up to 2 years
Title
Quality of life, assessed using the MD Anderson Symptom Inventory-Spine Tumor form
Description
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. The ratings in the MDASI can be averaged into several subscale scores: mean core symptom severity, mean module symptom severity, mean total symptom severity, and mean interference. The interference items can further be broken down into mean activity interference and mean affective interference. Symptom items may be presented individually
Time Frame
Up to 2 years
Title
Local control
Description
Will estimate time to first local failure curves using the Kaplan-Meier method.
Time Frame
Up to 2 years
Title
Overall survival
Description
Will use the Kaplan-Meier method.
Time Frame
Up to 2 years
Title
Incidence of post-treatment adverse events
Description
Will estimate the difference in grade 3+ toxicity rates, with 95% confidence intervals and a chi-squared test p-value.
Time Frame
Up to 2 years
Title
Radiographic vertebral body fracture, pain control and quality of life assessment
Description
Will assess the relationship between radiographic vertebral body fracture, pain control and quality of life using correlation analyses. Additional analyses may be conducted as appropriate.
Time Frame
Up to 2 years
Title
Quality of life, assessed using the EuroQol 5-dimensional 5-level questionnaire.
Description
Will use mixed effects linear models to analyze this longitudinal data. The questionnaire consists 2 parts. Part 1 is descriptive system (participants are asked mobility, self-care status, usual activities, pain/discomfort, anxiety/depression, and each dimension has 5 levels; Part 2 is the Visual analogue scale (the self-rated health today with score 0-100; 100 means the best health you can imagine. 0 means the worst health you can imagine) Part 2, participants give self-rated health today with 100 means the best health you can imagine. 0 means the worst health you can imagine. Part 2, higher range represents a better outcome
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have histologic proof of solid tumor malignancy and radiographic evidence of spine metastasis Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%) Life expectancy of greater than 3 months All patients must be able to lie supine All patients must have no more than 3 contiguous vertebral body levels treated at a single site, and no more than 3 discontiguous vertebral body levels treated All patients must have a single fraction spine radiosurgery at the designated site of interest to at least a dose of 18 Gray (Gy) All patients must be deemed at "high risk" of developing vertebral body fracture by having at least one of the following characteristics: Spine Instability Neoplastic Score classification of "Indeterminate" deemed as a score from 7 to 12 Pre-existing vertebral body fracture Planned radiation dose of 24 Gy All patients must have a vertebral body site to be treated located from T1 to L5 Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to 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 All patients must sign informed consent verifying that they are aware of the investigational nature of this study in keeping with the rules and policies of M.D. Anderson Cancer Center; the only acceptable consent is the one approved by M.D. Anderson Institutional Review Board (IRB) Patients undergoing bisphosphonate therapy are allowed Exclusion Criteria: Patients who have had prior radiotherapy at the spine site and level to be treated Patients who have had prior surgery at the spine level to be treated to include prior cement augmentation, laminectomy, vertebrectomy, tumor debulking, instrumentation Patients with gross disease involving only the posterior elements Patients who have > 50% vertebral body collapse Patients unable to undergo magnetic resonance imaging (MRI) of the spine Patents with cord compression Patients deemed not be a candidate for cement augmentation for any reason Patients who have frank mechanical pain Patients with both pedicles involved with gross disease at the level of potential cement augmentation Pregnant women are excluded from this study Patients with a histology of lymphoma, myeloma and small cell lung cancer histologies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amol Ghia
Phone
713-563-2300
Email
ajghia@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amol J Ghia
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amol J. Ghia
Phone
713-563-2300
First Name & Middle Initial & Last Name & Degree
Amol J. Ghia

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center Website

Learn more about this trial

Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases

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