Clinical trial NCT02387905: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Metastatic Malignant Neoplasm in the Spine
Metastatic Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vertebral compression fracture rate
timeFrame: At 3 months
Secondary outcomes:
measure: Time to first new or progressive vertebral body fracture
timeFrame: Up to 2 years
measure: Pain control, assessed using the Brief Pain Inventory form
timeFrame: Up to 2 years
measure: Quality of life, assessed using the MD Anderson Symptom Inventory-Spine Tumor form
timeFrame: Up to 2 years
measure: Local control
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
measure: Incidence of post-treatment adverse events
timeFrame: Up to 2 years
measure: Radiographic vertebral body fracture, pain control and quality of life assessment
timeFrame: Up to 2 years
measure: Quality of life, assessed using the EuroQol 5-dimensional 5-level questionnaire.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Amol J Ghia
role: PRINCIPAL_INVESTIGATOR
References: