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

NCT01290562 | Completed Phase 2 DMC

• 1 other identifier: UHN REB 10-0540-C
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Metastases

Keywords

SBRT; spinal Metastases; Paraspinal Metastases; spinal Metastases and SBRT; Paraspinal Metastases and SBRT

Outcome Measures

Primary Outcomes (1)

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

  5 years

Secondary Outcomes (5)

• To determine prospective pain and functional outcome data using the Brief Pain Inventory questionnaire

  5 years

• To prospectively document quality of life outcomes for patients post-SBRT using the validated EORTC QLQ - BM22 and C-15 PAL

  5 years

• To determine pain flare prospective data by using the Pain Diary for first 10 days after radiation.

  5 years

• To prospectively evaluate neurologic outcomes using the ASIA questionnaire

  5 years

• To evaluate acute and late toxicity of RT using NCIC Common Toxicity Criteria v. 3.0

  5 years

Study Arms (1)

Stereotactic Body Radiotherapy (SBRT)

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

One or more high dose(s) of radiation to treat the tumour.

Stereotactic Body Radiotherapy (SBRT)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John Cho, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: April 27, 2017
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

CA (1)