Secondary Malignant Neoplasm of Spine Clinical Trial
Official title:
A Prospective Randomized Trial of Involved Versus Elective Target Definition in Stereotactic Spine Radiosurgery for Spinal Metastases
The spine is a common metastatic site for malignancy and it can lead to serious and
devastating events, including pain, neurological dysfunction, and reduction in quality of
life. The radiotherapy (RT) has been the mainstay for palliating painful spinal metastases
for the past decades. It is utilized to arrest the tumor growth, control pain, and stabilize
or improve skeletal and/or neurological function. One of the limitations of the conventional
radiotherapy is that radiation dose intensification is not achievable with conventional RT
techniques due to the dose-limiting spinal cord, which is close to the vertebral body and
sometimes encased by epidural lesion.
The management of patients with spine metastasis has undergone a great deal of change in the
past 10 years. The concept of radiosurgery, a high dose of radiation targeted to a
pathological entity and delivered in 1-5-fractions, has proven so successful at treating both
benign and malignant lesions that it changed the paradigm for radiation therapy. Clinical
experiences with high dose spine stereotactic radiosurgery (SSRS) for spinal metastases
demonstrated both safety and efficacy. Nontheless, the patterns of clinical practice of SSRS
varies considerably regarding the dose fractionation, target delineation, and dosimetry.
There is lack of evidence-based recommedations for SSRS.
In our prior clinical trial comparing single fraction and multiple fractions SSRS
(NCT02608866), single-fraction with 16 Gy is the preferred regimen for further evaluation
since it met the predefined primary endpoint and has lower risk of treatment failure compared
to the multiple-fraction arm. Regarding the target volume definition, the International Spine
Radiosurgery Consortium published concensus guidelines based on expert opinions and limited
case series. We proposed this randomized study to determine the preferred or acceptable
definition of target volume delineation in SSRS and to evaluate their toxicity, efficacy, and
patterns of failure. Our analysis will provide evidence-based recommendations as well as
predictive factors regarding the clinical practice of SSRS.
Although conventionally fractionated radiation therapy has been utilized for decades, the
rates of complete pain relief and local control for complex tumors are sub-optimal. The
management of patients with spine metastasis has undergone a great deal of change in the past
5 years. Improvements in neuroimaging, computer- assited treatment planning, and radiation
therapy techniques have led to the development of extracranial radiosurgery.
SSRS is rapidly being adopted in the clinic as preliminary applications of SSRS appears
promising. However, the role of SSRS remains in its infancy and lacked high-quality evidence
about the treatment schedule and lacked a solid understanding of the adverse events. The RTOG
0631 phase 2/3 study was initiated to determine whether a more intensive radiation dose
delivered by image guided 16-Gy dose single fraction SRS could improve pain control and
quality of life as compared with conventional EBRT in patients with localized spine
metastases. Our preliminary result from previus phase 2 stereotactic spine radiosurgery trial
(NCT02608866) also showed good local control with minimal side effects in the single fraction
16-Gy setting as compared with 3 fractions 24 -Gy SRS dose.
Accurate and approproate delineation of the target area is paramount to the utilization of
spine SBRT. Whethr the target volume should include the entire extent of tumor and the
involved anatomical compartment for intact vertebra metastasis or remained to be discussed.
Our preliminary showed that the overall treatment failure rate was only about 14% using the
definition of the treating the affected spinal lesions(invovled target ) instead of treating
the entire . Better dose coverage of the target vome with improved normal tissue protection
can be achived with invovled field treatment without compromising the local control. Since no
treamtent target consensus has been reached from current clinical practive evidence. It is
pivotal to establish and collect more treatment evidence for future spinal SBRT.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3
or higher adverse events between these two different target delineations. Thus, we proposed
the randomized study to determine the feasibility of using "Invovled Target Volume" versus
"Elective Target Volume" and tried to evaluate the toxicity profile and gain robust data as
well as predictive factors regarding the local control rate and risk of complications after
SSRS.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02608866 -
Single Versus Multiple Fractionated SSRS for Spinal Metastases
|
N/A |