Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for

Status Recruiting

Clinical Trial Summary

Spinal cord compression (SCC) is a devastating complication of advanced malignancy, and can cause significant deterioration in function and quality of life (QoL). The goal of treatment is to improve functional status and symptoms, but the optimal treatment regimen for these patients has not been thoroughly established. Many patients with SCC present with uncontrolled systemic disease and poor performance status, and are not eligible for standard surgical resection. They are generally treated with 3D conformal palliative RT (3DCRT) alone, however recent trials suggest that less than 70% of patients are ambulatory, that the re-establishment of ambulation in non-ambulatory patients is poor, and the duration of improvement is guarded with radiotherapy alone.

Recently, stereotactic body radiotherapy (SBRT) used alone or after previous radiotherapy to treat spinal metastasis has demonstrated superior results in pain control, tumour response and durability. SBRT requires time for careful planning, and many patients with neurologic symptoms must be treated immediately to prevent progression. Therefore the role of SBRT is still unclear in this patient population, although it seems to be a potential alternative to surgical decompression in patient not suitable for surgery. The investigators propose a feasibility study to investigate the potential benefits of dose escalation with a sequential SBRT boost to urgent 3D CRT in the setting of SCC. This regimen will allow inoperable patients to receive urgent 3DCRT while simultaneously creating the opportunity for superior outcomes with SBRT. The investigators also aim to characterize the effect on motor function and ambulation, pain and QoL. This study could stimulate further multi-center randomized trials in this area, improve motor function and patient-reported QoL, and contribute to improving oncology care in Canada in a meaningful way.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03529708
Study type	Interventional
Source	Juravinski Cancer Center
Contact	Elysia K Donovan, MD,FRCPC
Phone	9053879495
Email	donovane@hhsc.ca
Status	Recruiting
Phase	N/A
Start date	June 1, 2018
Completion date	December 1, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05023772` - Laser Interstitial Thermal Ablation and Stereotactic Radiosurgery for Patients With Spine Metastases	N/A
Not yet recruiting	`NCT06077071` - MRIdian "RADAR" Trial	N/A
Not yet recruiting	`NCT02934594` - Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate	N/A
Completed	`NCT02926391` - UNiD 3D VBR Register
Recruiting	`NCT01826058` - Spine Stereotactic Body Radiation Therapy for Metastatic Epidural Spinal Cord Compression	Phase 2
Completed	`NCT00974168` - Spinal Cord Compression Re-Treat Study	Phase 2
Completed	`NCT00727584` - Radiation Therapy in Treating Patients With Metastatic Spinal Cord Compression	N/A
Terminated	`NCT00215527` - Intrathecal Enzyme Replacement Therapy for Spinal Cord Compression in Mucopolysaccharidosis (MPS) I	Phase 1
Completed	`NCT00280306` - White Matter Fiber Tracking and Assessment of White Matter Integrity in the Cervical Spinal Cord	N/A
Completed	`NCT02527304` - Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery	N/A
Terminated	`NCT01407341` - Beta-Tricalcium Phosphate Bone Graft in Treating Patients Undergoing Surgery For Metastatic Spine Cancer	Phase 1
Recruiting	`NCT05910593` - Establishing the Validity and Reliability of a Dexterity Assessment Tool
Terminated	`NCT02167633` - Stereotactic Radiosurgery in Metastatic Spinal Cord Compression	N/A
Enrolling by invitation	`NCT03225625` - Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study	N/A
Completed	`NCT04925882` - Erector Spinae Plane Block in Lumbar Release Surgery	N/A
Completed	`NCT02006901` - Comparative Effectiveness of Microdecompression and Laminectomy for Central Lumbar Spinal Stenosis	N/A
Terminated	`NCT00786968` - Extension Study of Intrathecal Enzyme Replacement Therapy for MPS I	Phase 1
Completed	`NCT00968643` - Spinal Cord Compression. ICORG 05-03, V6	Phase 3
Recruiting	`NCT05530798` - CEUS For Intraoperative Spinal Cord Injury	N/A
Completed	`NCT02713269` - Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression — CRUSSH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms