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Stereotactic Body Radiotherapy Boost After Palliative Radiotherapy for Spinal Cord Compression (CRUSSH)

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ClinicalTrials.gov Identifier: NCT03529708
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Juravinski Cancer Centre Foundation
Information provided by (Responsible Party):
Elysia Donovan, Juravinski Cancer Center

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Compression Cauda Equina Syndrome Stereotactic Body Radiotherapy Radiation: 3D CRT plus SBRT boost Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm pilot study of standard of care 3D conformal radiotherapy plus Stereotactic body radiotherapy (SBRT) boost
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
Experimental: SBRT boost
Standard radiotherapy (3D conformal, urgent palliative radiotherapy) plus stereotactic body radiotherapy (SBRT) boost
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.




Primary Outcome Measures :
  1. Feasibility of accrual [ Time Frame: up to 12 months ]
    Success determined by accrual of 30 patients with SBRT boost is planned and delivered to 80% of these


Secondary Outcome Measures :
  1. Motor Function Description: [ Time Frame: 4 weeks (primary), 12 weeks, 6 months ]
    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)

  2. Overall Quality of Life (QoL) [ Time Frame: 4 weeks, 12 weeks, 6 months ]
    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)

  3. Pain Response [ Time Frame: 4 weeks, 12 weeks, 6 months ]
    Change in level of pain over time on 10 point scale with 0 meaning no pain and 10 meaning severe pain (patient-reported)

  4. Local Control [ Time Frame: 12 weeks, 6 months ]
    Assessment of tumor volume (maximum size in 3 dimension) by Magnetic Resonance Imaging (MRI)

  5. Toxicity [ Time Frame: 4 weeks, 12 weeks, 6 months ]
    Treatment-related toxicity graded by Common Terminology for Adverse Events (CTCAE 4.03)

  6. Overall Survival [ Time Frame: 4 weeks, 12 weeks, 6 months ]
    Survival time from first radiotherapy treatment (3D CRT) in days

  7. Bone metastasis- specific Quality of Life [ Time Frame: 4 weeks, 12 weeks, 6 months ]
    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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529708


Contacts
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Contact: Elysia K Donovan, MD,FRCPC 9053879495 donovane@hhsc.ca
Contact: Shelley Chambers, MA 9053879495

Sponsors and Collaborators
Juravinski Cancer Center
Hamilton Health Sciences Corporation
Juravinski Cancer Centre Foundation

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Responsible Party: Elysia Donovan, Elysia Donovan, MD FRCPC, Radiation Oncology Fellow McMaster University, Juravinski Cancer Center
ClinicalTrials.gov Identifier: NCT03529708     History of Changes
Other Study ID Numbers: 4760
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Compression
Cauda Equina Syndrome
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