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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01290562
First received: February 3, 2011
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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. These patients will be treated with either 20-24 Gy in one fraction (recommended); 20-24 Gy in two fractions; or 20-24 Gy in three fractions. Cohort 2: patients with spinal metastases with a history of previous radiation to the affected spinal segment. These 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. Cohort 3: post-operative patients with spinal metastases with or without a history of previous radiation to the affected spinal segment. These 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.


Condition Intervention Phase
Patients With Paraspinal or Paraspinal Metastases
Radiation: Stereotactic Body Radiotherapy (SBRT)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To prospectively evaluate neurologic outcomes using the ASIA questionnaire [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0 [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: June 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy Alone Radiation: Stereotactic Body Radiotherapy (SBRT)
One or more high dose(s) of radiation to treat the tumour.
No Intervention: No Radiotherapy
Experimental: Radiotherapy plus Surgery Radiation: Stereotactic Body Radiotherapy (SBRT)
One or more high dose(s) of radiation to treat the tumour.
No Intervention: Surgery Alone

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290562

Contacts
Contact: John Cho, MD 416 946 4501 ext 2124 John.Cho@rmp.uhn.on.ca

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: John Cho, MD    416 946 4501 ext 2124    John.Cho@rmp.uhn.on.ca   
Principal Investigator: John Cho, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: John Cho, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01290562     History of Changes
Other Study ID Numbers: UHN REB 10-0540-C
Study First Received: February 3, 2011
Last Updated: June 2, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
SBRT
spinal Metastases
Paraspinal Metastases
spinal Metastases and SBRT
Paraspinal Metastases and SBRT

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014