Spinal Cord Compression Clinical Trial
— CRUSSHOfficial title:
Stereotactic Body Radiotherapy (SBRT) Boost Following Urgent 3D Conformal Radiotherapy in the Treatment of Metastatic Epidural Spinal Cord Compression (SCC): A Phase I Feasibility Trial
NCT number | NCT03529708 |
Other study ID # | 4760 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 1, 2020 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Diagnosis of metastatic malignancy (radiologic or pathologic) 2. Evidence of disease in vertebral body with epidural component such that Bilsky radiologic score is 1c-2 on MRI (abuts spinal cord without cord compression (1c), or spinal cord compression but with visible CSF (2) 3. Motor function (MF) of 3 or greater Exclusion Criteria: 1. Surgical candidate 2. Instability of vertebral bodies with or without bony retropulsion requiring surgical intervention or hardware placement 3. Previous radiotherapy course to same region of spine with overlapping fields (prior to phase I course) at discretion of treating radiation oncologist 4. No CT or MRI within previous 3 months 5. Life expectancy estimated <3 months 6. Performance status KPS<40 7. On active chemotherapy or targeted therapy or immunotherapy (must be stopped for at least one week prior to and following) 8. Pregnant or lactating 9. Contraindications to radiotherapy (eg. active autoimmune disease requiring medication) 10. Inability to lie flat comfortably for at least 20 minutes 11. Age < 18 |
Country | Name | City | State |
---|---|---|---|
Canada | Juravinski Cancer Center | Hamilton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Juravinski Cancer Center | Hamilton Health Sciences Corporation, Juravinski Cancer Centre Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of accrual | Success determined by accrual of 30 patients with SBRT boost is planned and delivered to 80% of these | up to 12 months | |
Secondary | Motor Function Description: | Motor strength evaluated by 8 point scale (0= Complete paraplegia, 1= Palpable or visible muscle contractions, 2= Active movement of the leg without gravity, 3= Active movement of the leg against gravity, 4= Active movement againt mild resistance, 5= Active movement against intermediate resistance, 6= Active movement against strong resistance, 7= Normal strength) | 4 weeks (primary), 12 weeks, 6 months | |
Secondary | Overall Quality of Life (QoL) | Change in total QoL score over time per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-c30) | 4 weeks, 12 weeks, 6 months | |
Secondary | Pain Response | Change in level of pain over time on 10 point scale with 0 meaning no pain and 10 meaning severe pain (patient-reported) | 4 weeks, 12 weeks, 6 months | |
Secondary | Local Control | Assessment of tumor volume (maximum size in 3 dimension) by Magnetic Resonance Imaging (MRI) | 12 weeks, 6 months | |
Secondary | Toxicity | Treatment-related toxicity graded by Common Terminology for Adverse Events (CTCAE 4.03) | 4 weeks, 12 weeks, 6 months | |
Secondary | Overall Survival | Survival time from first radiotherapy treatment (3D CRT) in days | 4 weeks, 12 weeks, 6 months | |
Secondary | Bone metastasis- specific Quality of Life | Change in total QoL score over time per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Bone Metastasis-22 (EORTC QLQ BM-22) | 4 weeks, 12 weeks, 6 months |
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