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Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)

Primary Purpose

Spinal Metastases

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Stereotactic Body Radiotherapy (SBRT)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Metastases focused on measuring SBRT, spinal Metastases, Paraspinal Metastases, spinal Metastases and SBRT, Paraspinal Metastases and SBRT

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Solitary or oligometastatic spine disease (maximum 5 sites of metastases), or bone only metastatic disease (regardless of the number) in otherwise high performance status patients, or patients with diffuse metastatic disease where the patient survival is expected to be at least 6 months
  • Maximum of 2 consecutive spinal segments involved by tumor for treatment otherwise a maximum of 3 sites within the spine to be treated in a single session
  • Previously irradiated: up to one course where the maximum BED previously delivered is no more than 100 Gy2 (50 Gy2/2) and >5 month interval from prior radiation to planned SBRT (Cohort 2) or first part of cohort 3
  • Karnofsky Performance Status >60
  • Had an MRI or CT documented spinal tumor and MRI of full spine no more than 8 weeks prior to SBRT (if patients cannot have a MRI then a CT myelogram is required)
  • Had a histological confirmation of neoplastic disease
  • Expected to have survival of > 3 months regardless of the number of metastases
  • Able to lie still and in a supine position on the treatment couch for up to 1 hour
  • Age >18
  • Adequate Bowel or urinary function

Exclusion Criteria:

  • A Pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely
  • Scleroderma or connective tissue disease as a contra-indication to radiotherapy
  • Unable to lie supine (i.e. tolerate treatment)
  • Previously treated with any radionuclides within 30 days prior to SBRT
  • Had external beam radiotherapy to the same area less than 5 months prior to SBRT and/or a course of radiation previously delivered >100 Gy2 (50 Gy2/2)
  • Significant or progressive neurologic deficit
  • Malignant epidural spinal cord compression or cauda equina syndrome
  • Spine instability, or neurological deficit resulting from bony compression of neural structures
  • Receiving chemotherapy for at least 1 week prior to SBRT and chemotherapy for one week following SBRT
  • Expected patient survival < 3 months

Sites / Locations

  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Body Radiotherapy (SBRT)

Arm Description

Cohort 1: Patients with spinal metastases and no prior radiation Cohort 2: Patients with spinal metastases in a previously radiated field Cohort 3: Post-operative patients with spinal metastases

Outcomes

Primary Outcome Measures

To determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria

Secondary Outcome Measures

To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire
To prospectively document quality of life outcomes for patients post-SBRT using the validated EORTC QLQ - BM22 and C-15 PAL
To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation.
To prospectively evaluate neurologic outcomes using the ASIA questionnaire
To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0

Full Information

First Posted
February 3, 2011
Last Updated
May 2, 2017
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01290562
Brief Title
Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)
Official Title
A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with new or recurrent spine metastases are currently treated with low doses of radiation delivered in up to ten treatments (wide-field radiation therapy). Stererotactic body radiotherapy (SBRT) is a technique in which high doses of radiation targeted precisely to the metastases to be treated are administered in a small number of sessions, thus reducing the radiation damage to the surrounding tissue and areas of the spine. The purpose of this study is to evaluate the efficacy of spine SBRT as an alternative to conventional radiation for patients with no prior radiation, prior radiation, and in the post-operative patient
Detailed Description
Spine SBRT is currently being practiced as an alternative to conventional wide-field radiation in the up-front management of spinal metastases, in the re-irradiation scenario, and in the post-operative setting. This study proposes to treat patients with a uniform spine SBRT approach, and collect prospective outcome data as a basis for future randomized trial design. Preliminary evaluation of our technique has yielded acceptable accuracy in treatment delivery as compared to the literature, and our practice follows current standards in major university hospitals performing this technique. Furthermore, preliminary data also suggest efficacy and safety for patients treated with SBRT for spinal metastases in a previously radiated field. However, well defined prospective outcomes are lacking in this patient group. There a 3 cohorts for this study each with a target accrual of 30 patients. Cohort 1: patients with spinal metastases and no prior radiation. Cohort 2: patients with spinal metastases with a history of previous radiation to the affected spinal segment. Cohort 3: post-operative patients with spinal metastases with or without a history of previous radiation to the affected spinal segment. All patients will be treated with either 20-24 Gy in one fraction (recommended) or 20-24 Gy in two fractions, or 20-24 Gy in three fractions. There is also and optional imaging component of this study. The purpose of the study is to determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Metastases
Keywords
SBRT, spinal Metastases, Paraspinal Metastases, spinal Metastases and SBRT, Paraspinal Metastases and SBRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiotherapy (SBRT)
Arm Type
Experimental
Arm Description
Cohort 1: Patients with spinal metastases and no prior radiation Cohort 2: Patients with spinal metastases in a previously radiated field Cohort 3: Post-operative patients with spinal metastases
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiotherapy (SBRT)
Intervention Description
One or more high dose(s) of radiation to treat the tumour.
Primary Outcome Measure Information:
Title
To determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria
Time Frame
5 years
Secondary Outcome Measure Information:
Title
To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire
Time Frame
5 years
Title
To prospectively document quality of life outcomes for patients post-SBRT using the validated EORTC QLQ - BM22 and C-15 PAL
Time Frame
5 years
Title
To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation.
Time Frame
5 years
Title
To prospectively evaluate neurologic outcomes using the ASIA questionnaire
Time Frame
5 years
Title
To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Solitary or oligometastatic spine disease (maximum 5 sites of metastases), or bone only metastatic disease (regardless of the number) in otherwise high performance status patients, or patients with diffuse metastatic disease where the patient survival is expected to be at least 6 months Maximum of 2 consecutive spinal segments involved by tumor for treatment otherwise a maximum of 3 sites within the spine to be treated in a single session Previously irradiated: up to one course where the maximum BED previously delivered is no more than 100 Gy2 (50 Gy2/2) and >5 month interval from prior radiation to planned SBRT (Cohort 2) or first part of cohort 3 Karnofsky Performance Status >60 Had an MRI or CT documented spinal tumor and MRI of full spine no more than 8 weeks prior to SBRT (if patients cannot have a MRI then a CT myelogram is required) Had a histological confirmation of neoplastic disease Expected to have survival of > 3 months regardless of the number of metastases Able to lie still and in a supine position on the treatment couch for up to 1 hour Age >18 Adequate Bowel or urinary function Exclusion Criteria: A Pacemaker such that MRI cannot be performed or the treatment cannot be delivered safely Scleroderma or connective tissue disease as a contra-indication to radiotherapy Unable to lie supine (i.e. tolerate treatment) Previously treated with any radionuclides within 30 days prior to SBRT Had external beam radiotherapy to the same area less than 5 months prior to SBRT and/or a course of radiation previously delivered >100 Gy2 (50 Gy2/2) Significant or progressive neurologic deficit Malignant epidural spinal cord compression or cauda equina syndrome Spine instability, or neurological deficit resulting from bony compression of neural structures Receiving chemotherapy for at least 1 week prior to SBRT and chemotherapy for one week following SBRT Expected patient survival < 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Cho, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases (Spine SBRT)

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