Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02987153 |
Other study ID # |
15-298 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 2016 |
Est. completion date |
October 2022 |
Study information
Verified date |
October 2022 |
Source |
Northwell Health |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Kypho-IORT is a novel approach to combine kyphoplasty, a minimally invasive procedure, with a
single dose of intraoperative radiotherapy (IORT) for the treatment of unstable or
potentially unstable spinal cord metastases. The primary objective is to evaluate the
response rate of pain control when combining kyphoplasty, a minimally invasive procedure,
with a single dose of intraoperative radio- therapy (IORT) for the treatment of spinal cord
metastases. Secondary objectives are (i.) to determine feasibility for unstable or potential
unstable spine metastases; (ii.) to determine tolerability/side effects of the IORT within 90
days post-procedure; (iii.) to determine which clinical factors are prognostic of vertebral
compression fracture
Description:
Approximately 20% of patients with spine metastasis present with unstable lesions, which
represent a common therapeutic dilemma in patients with advanced stage cancer and limited
survival time. Management necessitates spinal stabilization surgery such as laminectomy,
vertebroplasty, or kyphoplasty for mechanical back pain control and irradiation for the
underlying malignant process. Because of the limited survival time of patients with
metastatic cancer, novel, more convenient treatment concepts to shorten the overall treatment
time or hospitalization are desirable. We developed a novel approach to combine kyphoplasty,
a minimally invasive procedure, with a single dose of intraoperative radio- therapy (IORT)
for the treatment of spinal cord metastases.
Patients treated with Kypho-IORT will receive a prescribed dose of 8 Gy in 1 fraction from
The Intrabeam® Photon Radiosurgery System source. The target volume includes only the tumor.
The technique of the operation and the delivery of radiotherapy has been described and
published previously. TARGiT Academy training and requisite test cases have been completed
prior to enrolling subjects on this study. The balloon kyphoplasty, which is an advancement
of the vertebroplasty, is a treatment option for fractured vertebral bodies which utilizes
bone cement to provide needed support.
Outcome measures will include complete or partial pain relief or a stable response at the
index site requiring no increase in narcotic pain medication. Therefore, patients with
complete or partial pain relief will be considered responders. Patients with complete or
partial pain relief at the index site but a progressive response at the secondary site(s)
will be considered non-responders.
Quality of Life Measurements. It is hypothesized that quality of life (QOL) will improve
after Kypho-IORT due to rapid and durable pain control after spine treatment. In the current
study, we will measure the QOL [EORTC QLQ-C30 (version 3)], the Brief Pain Inventory (BPI),
ambulation , and steroid and narcotic use pre- and post-procedure at 1-week, 3-month,
6-month, 9-month, 1-year, and 2-year intervals. The involved spine will be imaged at 3-month
intervals up to one year, and at 2 years post-procedure.
All the evidence to date supports the description of the Intrabeam as delivering an accurate
and reliable dose. Physicists on site will be responsible for verifying the miniature x-ray
source is operational prior to use and setting up the parameters within the control console
software for treatment delivery. During the procedure, the control console monitors the
system for safe and accurate dose delivery.