Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality (NCT06884332) | Clinical Trial Compass
RecruitingNot Applicable
Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
France598 participantsStarted 2025-07-02
Plain-language summary
The goal of this clinical trial is to assess the impact of reducing the volume of palliative metastatic bone irradiation on analgesic effectiveness at day 30 and to evaluate the efficiency of telemonitoring in identifying patients who could benefit from Patient-Reported Outcomes (PROs) and require care.
These objectives will be addressed in a multicenter, randomized, prospective study with two arms:
A standard arm with spinal irradiation without sparing the adjacent vertebrae. An experimental arm with spinal irradiation sparing the adjacent vertebrae. The results will determine whether reducing the irradiated volume can maintain effective pain relief while minimizing side effects.
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:
* Patient with bone pain related to at least 1 or more bone metastases of spinal location, contiguous or not, cervical (excluding C1), thoracic, lumbar or sacral up to and including S2; a patient can be included even if he or she is irradiated concomitantly or not for analgesic purposes on another non-spinal bone metastatic site. Bone lesions are objective on an imaging examination less than 3 months old: CT and/or MRI and/or PET and/or bone scintigraphy;
* Patient with at least moderate pain with EN ≥ 5;
* Patient on analgesic drug treatment for at least 7 days or poor tolerance of analgesics;
* Patient irradiated for palliative analgesic purposes. Post-cementoplasty irradiation is possible; an extension to the soft tissues is not a contraindication to inclusion;
* Patient with a validated palliative bone irradiation plan: 8 Gy / 1 fr or 20 Gy / 5 fr;
* Patient with planning only in static IMRT, arc therapy or helical tomotherapy;
* Patient with a primary cancer or a haemopathy;
* Patient currently undergoing or not a specific oncological systemic treatment, left to the discretion of the investigating physician;
* Patient currently undergoing or not a treatment with bisphosphonates and denosumab, left to the discretion of the investigating physician;
* WHO ≤ 2;
* Patient with a life expectancy ≥ 3 months;
* Patient able and agreeing to follow all study procedures in accordance with the protocol;
* Patient having understood, signed and dated the consent f…
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
Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy
Timeframe: From enrollment to the end of treatment at day 30 after the first irradiation.