A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases (NCT02700308) | Clinical Trial Compass
TerminatedPhase 2
A Study of Kyphoplasty and Vertebroplasty in the Treatment of Spine Metastases
Stopped: DECISION OF THE SPONSOR AND THE COORDINATING INVESTIGATOR DUE TO RECRUITMENT DIFFICULTIES AND CHANGES IN INTERVENTIONAL RADIOLOGY PRACTICES
France31 participantsStarted 2016-03
Plain-language summary
Conventional vertebroplasty is an effective option in the treatment of bone lesions (osteoporotic and neoplastic). It is indicated as an analgesic treatment and aims at reinforcing a compressed vertebrae or at risk of fracture.
The main adverse event related to vertebroplasty use is the cement leakages that might be responsible for significant clinical impairments.
Kyphoplasty is a recent alternative strategy of vertebroplasty, based on the insertion on balloon through the needle into the targeted vertebrae and then inflation of the balloon prior to cement injection into the space.
In an osteoporotic setting, kyphoplasty allow reducing the incidence of cement leakage.
To date, no data from randomized study are available in the population of cancer patients.
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:
* Diagnosis of cancer other than malignant hemopathies, myeloma, brain tumors, germ-cell tumors and bone sarcomas;
* 2 metastatic sites or more;
* Spine metastasis between T1 and L5 with reduction of vertebrae of 20% at least;
* Indication of cementoplasty of 1 to 6 vertebrae defined by 1 of the following:
* Pain equal or greater than 4/10 at Visual Analogic Scale
* Unstable vertebrae (SINS score equal or greater than 7;
* Performance Status of the Eastern Cooperative Oncology Group : 0, 1 or 2
Exclusion Criteria:
* Contraindication to vertebroplasty, including contraindication to cement use;
* Patient already treated by vertebroplasty within the past 3 months (1 patient can not be allocated twice in this study);
* Previous focal treatment of the targeted vertebrae (vertebroplasty, percutaneous radiofrequency, embolization);
* Neurological deficit due to medullar or radicular compression;
* Participation to another clinical trial with an analgesic intent.
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.