This trial is active, not recruiting.

Condition spinal metastases
Treatment stereotactic body radiotherapy (sbrt)
Phase phase 2
Sponsor University Health Network, Toronto
Start date June 2011
End date September 2016
Trial size 90 participants
Trial identifier NCT01290562, UHN REB 10-0540-C


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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
stereotactic body radiotherapy (sbrt)
One or more high dose(s) of radiation to treat the tumour.

Primary Outcomes

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 Outcomes

To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire
time frame: 5 years
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
To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation.
time frame: 5 years
To prospectively evaluate neurologic outcomes using the ASIA questionnaire
time frame: 5 years
To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0
time frame: 5 years

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases
Principal investigator John Cho, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.