MedTrace Logo

Involved Versus Elective Target SSRS for Spinal Metastases

NCT04033536 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2019-07-26

No results posted yet for this study

Summary

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.

Conditions

  • Secondary Malignant Neoplasm of Spine

Interventions

RADIATION

Involved Target Stereotacic Spine Radiosurgery

Image guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Involved Target using IMRT/VMAT/RapidArc

RADIATION

Elective Target Stereotacic Spine Radiosurgery

Image guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Elective Target using IMRT/VMAT/RapidArc

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Feng-Ming Hsu, M.D., Ph.D · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2022-06-30
Completion
2024-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033536 on ClinicalTrials.gov