Secondary Malignant Neoplasm of Spine Clinical Trial
Official title:
A Prospective Randomized Clinical Trial of Single Versus Multiple Fractionated Stereotactic Spine Radiosurgery for Patients With Spinal Metastases
The investigators proposed this randomized study to determine the feasibility of delivering single-fraction 16-Gy versus 3-fraction 24-Gy toward spine metastatic lesion and to evaluate their toxicity profiles. The investigators' analysis will provide robust data as well as predictive factors regarding the outcome after 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-assisted 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
Radiation Therapy Oncology Group (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
external-beam radiotherapy in patients with localized spine metastases . While other group
used treatment schedule in a total dose of 27-30 Gy in three fractions.
Serious adverse events such as vertebral compression fracture (VCF) is a fairly low-risk
adverse event after conventional radiotherapy, nevertheless, the crude risk estimates for VCF
after spinal stereotactic body radiation therapy is relative more frequent. Previous reports
has raised the caution about the given dose and predictive factors, however; whether these
two most widely used SSRS schedule (ie. single fraction versus three fractions) provide
equivalent pain control and minimal side effects remained to be answered.
There was no randomized trials to assess the SSRS treatment response and SSRS induced grade 3
or higher adverse events between the two most widely adopted scheme. Thus, the investigators
proposed the randomized study to determine the feasibility of delivering a single 16-Gy SRS
dose versus 3 fractions 24-Gy SRS dose and tried to evaluate the toxicity profile and gain
robust data as well as predictive factors regarding the risk of complications after SSRS,
including VCF. The investigators will incorporate the recently developed and reported
reliable Spinal Instability Neoplastic Scoring (SINS) system and well-designed patient
reported outcome measures (PROMs) into the protocol to predict the adverse event and quality
of life of each participant. The researchers also tried to investigate the possible
associations of the potential bone biomarkers for the risk assessment of SSRS-related adverse
bone events.
Since the patients were randomized for treatment arms, the effectiveness of SSRS treatment
scheme and adverse profile can be investigated more properly in the present study.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04033536 -
Involved Versus Elective Target SSRS for Spinal Metastases
|
N/A |