Spinal Metastases Clinical Trial
Official title:
A University of Toronto Phase II Study to Determine Efficacy of Stereotactic Body Radiotherapy (SBRT) for Spinal/Para-Spinal Metastases
Verified date | May 2017 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 90 |
Est. completion date | April 27, 2017 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network, Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the efficacy of spine SBRT in select groups of patients using image based and symptom based local control criteria | 5 years | ||
Secondary | To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire | 5 years | ||
Secondary | To prospectively document quality of life outcomes for patients post-SBRT using the validated EORTC QLQ - BM22 and C-15 PAL | 5 years | ||
Secondary | To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation. | 5 years | ||
Secondary | To prospectively evaluate neurologic outcomes using the ASIA questionnaire | 5 years | ||
Secondary | To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0 | 5 years |
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