A Phase II Trial Evaluating Radiation Boost to Painful Spinal Metastases
ConditionSpine Metastasis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
Spine SBRT is considered a standard of care for the treatment of spinal metastases. Compared to conventional radiation therapy, spine SBRT delivers high doses of radiation to the affected areas to the spinal metastases.
This study is interested in seeing whether an additional 'boost' of radiation, delivered to the affected area in the spine, will result in better long-term control of the tumor; help reduce pain; and reduce long-term side effects of radiation therapy.
Eligibility criteria
Qualifiers
Histopathologically confirmed solid tumor malignancy, or strong suspicion based on clinical and radiographic examination of malignancy
Spinal metastases with paraspinal disease extension documented with MRI and recommended for treatment with SBRT
Post-operative SBRT is permitted (after stabilization and/or decompression surgery) as long as no prior radiotherapy had been delivered to the spinal level planned for trial treatment and paraspinal disease is present
ECOG performance status 0-2
Disqualifiers
Extremely radiosensitive histology (seminoma, small cell lung cancer, hematologic primaries)
Prior radiotherapy in the spine target of interest
Spinal instability as assessed by the Spinal Instability Neoplastic Score with a score of > 12
Symptomatic cord compression or cauda equine syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina, respectively. Symptomatic refers to neurologic deficit in the form of motor, bowel or bladder dysfunction
Trial design
Treatments tested in this trial
- Radiation Boost
Treatment groups
108 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov