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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Radiation Boost
RadiationAn additional boost of radiation will be delivered to the spinal metastases. The amount of boost depends on how much radiation would have been normally prescribed (e.g., if treatment required 2 fractions of radiation treatment, an additional 2 Gy would be prescribed; if treatment required 4 fractions of radiation treatment, an additional 4 Gy would be prescribed; if treatment required 5 fractions of radiation treatment, an additional 5 Gy would be prescribed).
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: Radiation BoostExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Disease Progression within the Treated Spinal Metastasis, in accordance with SPINO (SPIne assessment in Neuro-Oncology) guidelines
Time frame
Up to 12 months after completion of radiation therapySecondary outcomes
1
Pain at treated spinal metastases, per ICPRE (International Consensus on Palliative Radiotherapy Endpoints)
Time frame
3 and 6 months following completion of radiation therapy2
Type of progression
Whether the progression occurred at local, marginal, or distant location
Time frame
Up to 12 months after completion of radiation therapy3
Treatment-related side effects as assessed by CTCAE v5.0
Time frame
Up to 12 months following completion of radiation therapy4
Spinal Instability, as assessed through the Spinal Instability Neoplastic Scores (SINS)
Time frame
Up to 12 months following completion of radiation therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov