Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression

Spinal Cord Compression Clinical Trial

— CRUSSH  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03529708
• Other study ID #: 4760
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2020
• Source: Juravinski Cancer Center
• Contact: Elysia K Donovan, MD,FRCPC
• Phone: 9053879495
• Email: donovane[@]hhsc.ca
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cauda Equina Syndrome
• Spinal Cord Compression
• Stereotactic Body Radiotherapy

Intervention

Radiation:
• 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.

Locations

Country	Name	City	State
Canada	Juravinski Cancer Center	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Juravinski Cancer Center	Hamilton Health Sciences Corporation, Juravinski Cancer Centre Foundation

Country where clinical trial is conducted

Canada, 

Outcome

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