Spinal Metastases Clinical Trial
Official title:
A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases
Patients with new or recurrent spine metastases are currently treated with low doses of
radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic
body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely
to the metastases to be treated are administered in a small number of sessions, thus
reducing the radiation damage to the surrounding tissue and areas of the spine.
The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to
conventional radiation for patients with no prior radiation, prior radiation, and in the
post-operative patient
Spine SBRT is currently being practiced as an alternative to conventional wide-field
radiation in the up-front management of spinal metastases, in the re-irradiation scenario,
and in the post-operative setting. This study proposes to treat patients with a uniform
spine SBRT approach, and collect prospective outcome data as a basis for future randomized
trial design. Preliminary evaluation of our technique has yielded acceptable accuracy in
treatment delivery as compared to the literature, and our practice follows current standards
in major university hospitals performing this technique. Furthermore, preliminary data also
suggest efficacy and safety for patients treated with SBRT for spinal metastases in a
previously radiated field. However, well defined prospective outcomes are lacking in this
patient group.
There a 3 cohorts for this study each with a target accrual of 30 patients. Cohort 1:
patients with spinal metastases and no prior radiation.
Cohort 2: patients with spinal metastases with a history of previous radiation to the
affected spinal segment.
Cohort 3: post-operative patients with spinal metastases with or without a history of
previous radiation to the affected spinal segment.
All patients will be treated with either 20-24 Gy in one fraction (recommended) or 20-24 Gy
in two fractions, or 20-24 Gy in three fractions. There is also and optional imaging
component of this study.
The purpose of the study is to determine the efficacy of spine SBRT in select groups of
patients using image based and symptom based local control criteria
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01347307 -
Stereotactic Body Radiotherapy for Spine Tumors
|
N/A | |
Terminated |
NCT00593320 -
Stereotactic Radiosurgery (SRS) for Spine Metastases
|
N/A | |
Recruiting |
NCT05575323 -
Randomized Trial on Same-day SBRT and Surgical Stabilization for Symptomatic Spinal Metastases
|
N/A | |
Completed |
NCT02987153 -
Kypho-Intra Operative Radiation Therapy (IORT) for Localized Spine Metastasis, Phase I/II Study
|
N/A | |
Recruiting |
NCT03363685 -
Verification of Novel Survival Prediction Algorithm for Patients With NSCLC Spinal Metastasis
|
||
Terminated |
NCT02407795 -
Conventional With Stereotactic Radiotherapy for Pain Reduction and Quality of Life in Spinal Metastases
|
N/A | |
Completed |
NCT01365715 -
Preoperative Embolization in Surgical Treatment of Spinal Metastases.
|
N/A | |
Recruiting |
NCT04863612 -
SBRT in the Management of Solid Spinal Metastases
|
||
Recruiting |
NCT04242589 -
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
|
Phase 2 | |
Recruiting |
NCT01849510 -
Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
|
Phase 2 | |
Not yet recruiting |
NCT06244264 -
The Safety and Efficacy of Autologous Transfusion in Spinal Surgery for Lung Cancer With Spinal Metastasis
|
N/A | |
Not yet recruiting |
NCT06220071 -
Multicentric European Study In Patients With Vertebral Metastases
|
||
Recruiting |
NCT06120426 -
En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.
|
||
Completed |
NCT03224650 -
Validation of Novel Predictive Score for Patients With Spinal Metastases
|
||
Completed |
NCT02512965 -
Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases
|
N/A | |
Not yet recruiting |
NCT06093854 -
Intraoperative Radiotherapy in Treating Spinal Metastases
|
N/A | |
Completed |
NCT02364115 -
Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study
|
N/A | |
Recruiting |
NCT03398915 -
The European Robotic Spinal Instrumentation (EUROSPIN) Study
|
||
Not yet recruiting |
NCT05173467 -
Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
|
N/A | |
Recruiting |
NCT04248543 -
Quantitative MRI for Functional Assessment Following SBRT for Spinal Metastases
|
N/A |