Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression

NCT03529708 | Unknown DMC

• 1 other identifier: 4760
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Motor Function Description:

  4 weeks (primary), 12 weeks, 6 months

• Overall Quality of Life (QoL)

  4 weeks, 12 weeks, 6 months

• Pain Response

  4 weeks, 12 weeks, 6 months

• Local Control

  12 weeks, 6 months

• Toxicity

  4 weeks, 12 weeks, 6 months

Study Arms (1)

SBRT boost

EXPERIMENTAL

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

Radiation: 3D CRT plus SBRT boost

Interventions

3D CRT plus SBRT boost RADIATION

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.

SBRT boost

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of metastatic malignancy (radiologic or pathologic)
• 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)
• Motor function (MF) of 3 or greater

You may not qualify if:

• Surgical candidate
• Instability of vertebral bodies with or without bony retropulsion requiring surgical intervention or hardware placement
• Previous radiotherapy course to same region of spine with overlapping fields (prior to phase I course) at discretion of treating radiation oncologist
• No CT or MRI within previous 3 months
• Life expectancy estimated \<3 months
• Performance status KPS\<40
• On active chemotherapy or targeted therapy or immunotherapy (must be stopped for at least one week prior to and following)
• Pregnant or lactating
• Contraindications to radiotherapy (eg. active autoimmune disease requiring medication)
• Inability to lie flat comfortably for at least 20 minutes
• Age \< 18

Sponsors & Collaborators

• Juravinski Cancer Center: lead
• Hamilton Health Sciences Corporation: collaborator
• Juravinski Cancer Centre Foundation: collaborator

Study Sites (1)

Juravinski Cancer Center

Hamilton, Ontario, L8V1C5, Canada

RECRUITING

Related Publications (1)

• Donovan EK, Greenspoon J, Schnarr KL, Whelan TJ, Wright JR, Hann C, Whitton A, Chow T, Parpia S, Swaminath A. A pilot study of stereotactic boost for malignant epidural spinal cord compression: clinical significance and initial dosimetric evaluation. Radiat Oncol. 2020 Nov 18;15(1):267. doi: 10.1186/s13014-020-01710-4.

  PMID: 33208170 DERIVED

MeSH Terms

Conditions

Spinal Cord Compression; Cauda Equina Syndrome

Interventions

Radiotherapy, Conformal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Injuries; Wounds and Injuries; Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Polyradiculoneuropathy; Polyneuropathies

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Elysia K Donovan, MD,FRCPC

CONTACT

9053879495; donovane@hhsc.ca

Shelley Chambers, MA

CONTACT

9053879495

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Elysia Donovan, MD FRCPC, Radiation Oncology, McMaster University

Model Details: Single arm pilot study of standard of care 3D conformal radiotherapy plus Stereotactic body radiotherapy (SBRT) boost

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 18, 2018
• Study Start: June 1, 2018
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)