Recruiting

Stereotactic Body Radiotherapy

Sponsor:

Juravinski Cancer Center

Code:

NCT03529708

Conditions

Spinal Cord Compression

Cauda Equina Syndrome

Stereotactic Body Radiotherapy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

3D CRT plus SBRT boost

Study Details

Brief 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.

Conditions

Spinal Cord Compression

Cauda Equina Syndrome

Stereotactic Body Radiotherapy

Study ID

NCT03529708

Start date

Jun 1, 2018

Status verified date

Jan, 2020

Completion date

Dec 1, 2020

Anticipated

Primary completion date

Jun 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SBRT boost

Standard radiotherapy (3D conformal, urgent palliative radiotherapy) plus stereotactic body radiotherapy (SBRT) boost

Interventions

3D CRT plus SBRT boost

Patients will receive urgent standard 3D conformal radiotherapy (3D CRT) of plus stereotactic boost to tumor causing spinal cord compression (SCC). Initial dose for 3D CRT will be either 8Gy in 1 fraction or 20Gy in 5 fractions, with SBRT boost dose15Gy in 2 fractions of 12Gy in 2 fractions (depending on 8Gy/1 or 20Gy/5 initial RT dose respectively), delivered within three weeks of first treatment.

Primary outcome measure

  • Feasibility of accrual [ Time Frame: up to 12 months ]

Central Contacts and Locations

Central contacts

Elysia K Donovan, MD,FRCPC

9053879495donovane@hhsc.ca

Shelley Chambers, MA

9053879495

Locations

Juravinski Cancer Center

Recruiting

Hamilton, Ontario, Canada, L8V1C5

More Information

Sponsor

Juravinski Cancer Center

Last update posted

Jan 29, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juravinski Cancer Center on 2020-01-29.