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
| NCT number | NCT04033536 |
| Other study ID # | 201905015RINC |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2019 |
| Est. completion date | June 2024 |
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.
| Status | Recruiting |
| Enrollment | 114 |
| Est. completion date | June 2024 |
| Est. primary completion date | June 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with a histologic diagnosis of non-hematopoietic malignancy - Radiographic evidence of localized spine metastases without leptomeningeal involvement or intramedullary lesion - Maximum four separate sites with a maximal involvement of two continuous vertebral levels - Patients do not have prior radiotherapy to the index spine(s) - Age = 20 years - Karnofsky performance status (KPS) = 60%. - Life expectancy of = 6 month. - Women of childbearing potential and male participants must practice adequate contraception - Patients must be able to comply with the study protocol and follow- up schedules and provide study-specific informed consent Exclusion Criteria: - Prior radiotherapy to the index spine(s) - Serum creatinine > 2.0 mg/dL within 90 days prior registration - Contraindication to MR imaging such as implanted metal devices or foreign bodies, severe claustrophobia - Patients with leptomeningeal involvement or intramedullary metastasis - Inability to tolerate treatment procedure - Bony retropulsion causing neurologic abnormality - Severe, active comorbidities which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and adverse events of the protocol, or limit compliance with study requirements - Will receive any other investigational agent or chemotherapy and/or target therapies during treatment - Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the radiation treatment involved in this study may be significantly teratogenic - Pregnant or breast-feeding women |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Treatment Failure Rate at 6 months after SSRS | The rate of predefined treatment failure at 6-month after stereotactic spine radiosurgery. Treatment failure is defined as Grade 3 or higher adverse events definitely, probably, or possibly related to treatment and/or unequivocal local progression indicative of surgical intervention or re-irradiation. | 6 months | |
| Secondary | Health-related quality of life for palliative cancer care | EORTC QLQ-C15-PAL Taiwan | 1-, 3-, and 6-month, and every 3 months thereafter until neurological progression, death, or up to 1 year after SSRS |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02608866 -
Single Versus Multiple Fractionated SSRS for Spinal Metastases
|
N/A |