Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients W… (NCT02364115) | Clinical Trial Compass
CompletedNot Applicable
Randomized Trial Comparing Conventional Radiotherapy With Stereotactic Radiotherapy in Patients With Bone Metastases - VERTICAL Study
Netherlands110 participantsStarted 2015-01
Plain-language summary
The purpose of the study is to investigate effectiveness of stereotactic body radiotherapy in patients with bone metastatic disease.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Radiographic evidence of bone metastases
* For spinal lesions; per lesion no more than 3 consecutive spine segments involved with one unaffected vertebral body above and below
* No more than 2 painful lesions needing treatment
* Histologic proof of malignancy
* No compression of spinal cord
* No or mild neurological signs (i.e. radiculopathy, dermatomal sensory change, and muscle strength of involved extremity is Medical Research Council (MRC) 4/5
* Medically inoperable or patient refused surgery
* Karnofsky performance score (KPS) \> 50
* Numeric rating scale (NRS) \> 3
* Age \> 18 years
* Written informed consent
* Filling out PRESENT-questionnaires
Exclusion Criteria:
* Lesion in C1 or C2
* Radio-sensitive histology such as multiple myeloma, lymphoma, small cell, germ cell
* Spinal MRI cannot be completed for any reason (in according with the MRI protocol of the Department of Radiology)
* Impossible to delineate metastasis and organs at risk (OAR) due to artifacts on CT or MRI from previous surgical stabilization
* Unable to undergo SBRT treatment, according to treating doctor's opinion
* Epidural disease
* Severe, worsening or progressive neurological deficit
* Unstable lesion requiring surgical stabilization
* Patient with \< 3 months life expectancy
* Previous EBRT or SBRT to same level
* Chemotherapy or systemic radionuclide delivery within 24 hours before and after SBRT
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete or partial pain response after radiation, defined according to the International Bone Metastases Consensus Endpoints for Clinical Trials.