Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study (Kypho-IORT)
Primary Purpose
Spinal Metastases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kypho-IORT
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Metastases focused on measuring Kyphoplasty, Spinal metastases, IORT, Intraoperative radiation therapy, Pain management
Eligibility Criteria
Inclusion Criteria:
- Karnofsky Index ≥ 60.
- History/physical examination within 4 weeks prior to procedure.
- Imaging of the involved spine within 8 weeks prior to procedure to determine the extent of the spine involvement.
- Numerical Rating Pain Scale within 4 week prior to procedure (score must be ≥ 5 for at least one of the planned sites for spinal IORT.
- Neurological examination within 4 week prior to procedure to rule out rapid neurologic decline.
- Spine Instability Neoplastic Score (SINS score) = ≤12.
- Negative serum pregnancy test within 4 weeks prior to procedure for women of childbearing potential.
- Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
- The patient must have localized spine metastasis from the T5 to L5 levels by a screening imaging study [bone scan, PET, CT, or MRI] (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted). Each of the separate sites have a maximal involvement of ONE vertebral body. Patients can have other visceral metastasis.
- Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
- Spine instability due to a compression fracture; SINS score >12.
- Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord
- Patients with rapid neurologic decline
- Bony retropulsion causing neurologic abnormality
- Patients allergic to contrast dye used in MRIs or CT scans or who cannot be premedicated for the use of contrast dye
Sites / Locations
- Northwell Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KYPHO-IORT - 10 Gy and Kyphoplasty
Arm Description
Intra-operative radiation therapy followed by standard kyphoplasty
Outcomes
Primary Outcome Measures
To evaluate pain control
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 Outcome Measures
Feasibility of Kypho-IORT as treatment modality
To determine the feasibility of delivered Kypho-IORT for unstable or potential unstable spine metastases.
Tolerability/side effects
To determine tolerability/side effects of the IORT based on defined MTD criteria (wound healing problems, infection, osteoradionecrosis, nerve and spinal cord damage, pathological fracture, secondary fractures/sintering progression and symptomatic or asymptomatic cement leakage within 90 days.
Local tumor control
Local tumor control is defined as no recurrent tumor in the treated lesion. Patients will be regularly monitored as per the site's policy provided this meets the minimum trial criteria for follow-up with physical examination 1 week post treatment, and at 3 months, 6 months, 1 year, and 2 years post-treatment.
Overall survival
Overall survival will be the time interval between enrollment and death.
Measures of quality of life.
Evaluate the potential benefit of Kypho-IORT on change in and overall quality of life, in pain as measured by the Brief Pain Inventory (BPI); Ambulation, and EORTC QLQ-C30 (version 3).
Steroid and narcotic use.
The average daily morphine equivalent (mgs) used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02987153
Brief Title
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
Acronym
Kypho-IORT
Official Title
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
October 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
Kyphoplasty, Spinal metastases, IORT, Intraoperative radiation therapy, Pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
KYPHO-IORT - 10 Gy and Kyphoplasty
Arm Type
Experimental
Arm Description
Intra-operative radiation therapy followed by standard kyphoplasty
Intervention Type
Radiation
Intervention Name(s)
Kypho-IORT
Other Intervention Name(s)
Intrabeam® Photon Radiosurgery System
Intervention Description
The radiation source is inserted into the lesion and switched on for a few minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and clinical applications of this device have been well studied.
Primary Outcome Measure Information:
Title
To evaluate pain control
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Feasibility of Kypho-IORT as treatment modality
Description
To determine the feasibility of delivered Kypho-IORT for unstable or potential unstable spine metastases.
Time Frame
90 days
Title
Tolerability/side effects
Description
To determine tolerability/side effects of the IORT based on defined MTD criteria (wound healing problems, infection, osteoradionecrosis, nerve and spinal cord damage, pathological fracture, secondary fractures/sintering progression and symptomatic or asymptomatic cement leakage within 90 days.
Time Frame
90 days
Title
Local tumor control
Description
Local tumor control is defined as no recurrent tumor in the treated lesion. Patients will be regularly monitored as per the site's policy provided this meets the minimum trial criteria for follow-up with physical examination 1 week post treatment, and at 3 months, 6 months, 1 year, and 2 years post-treatment.
Time Frame
2 years
Title
Overall survival
Description
Overall survival will be the time interval between enrollment and death.
Time Frame
2 years
Title
Measures of quality of life.
Description
Evaluate the potential benefit of Kypho-IORT on change in and overall quality of life, in pain as measured by the Brief Pain Inventory (BPI); Ambulation, and EORTC QLQ-C30 (version 3).
Time Frame
2 years
Title
Steroid and narcotic use.
Description
The average daily morphine equivalent (mgs) used.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Karnofsky Index ≥ 60.
History/physical examination within 4 weeks prior to procedure.
Imaging of the involved spine within 8 weeks prior to procedure to determine the extent of the spine involvement.
Numerical Rating Pain Scale within 4 week prior to procedure (score must be ≥ 5 for at least one of the planned sites for spinal IORT.
Neurological examination within 4 week prior to procedure to rule out rapid neurologic decline.
Spine Instability Neoplastic Score (SINS score) = ≤12.
Negative serum pregnancy test within 4 weeks prior to procedure for women of childbearing potential.
Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control.
The patient must have localized spine metastasis from the T5 to L5 levels by a screening imaging study [bone scan, PET, CT, or MRI] (a solitary spine metastasis; two separate spine levels; or up to 3 separate sites are permitted). Each of the separate sites have a maximal involvement of ONE vertebral body. Patients can have other visceral metastasis.
Patients must provide study specific informed consent prior to study entry.
Exclusion Criteria:
Spine instability due to a compression fracture; SINS score >12.
Frank spinal cord compression or displacement or epidural compression within 3 mm of the spinal cord
Patients with rapid neurologic decline
Bony retropulsion causing neurologic abnormality
Patients allergic to contrast dye used in MRIs or CT scans or who cannot be premedicated for the use of contrast dye
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged Ghaly, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Health
City
Lake Success
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Learn more about this trial
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
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