Status:
RECRUITING
Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
Lead Sponsor:
Institut de Cancérologie de Lorraine
Conditions:
Bone Metastasis
Oncology Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 telemoni...
Detailed Description
Palliative analgesic radiotherapy (RT) is used to relieve pain in patients with bone metastases. This technique involves irradiating the vertebrae above and below the ones responsible for the pain. Tr...
Eligibility Criteria
Inclusion
- 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 form;
- Patient affiliated to the social security system.
Exclusion
- Pediatric patient;
- Patient undergoing stereotaxic irradiation;
- Patient undergoing oligometastatic disease;
- Patient undergoing re-irradiation unless the dose is not limiting to OARs;
- Patient treated with RT2D (conventional 2-dimensional radiotherapy) or RT3D (conventional 3-dimensional radiotherapy);
- Patient with MESCC (metastatic epidural spinal cord compression) except for a Bilsky grade \< 1b;
- Patient who does not have a means of responding to online questionnaires;
- Patient and their entourage who cannot read or express themselves in French;
- Visually impaired patient;
- Patient already included in another therapeutic trial with an experimental molecule;
- Persons deprived of liberty or under guardianship (including curatorship).
- Pregnant woman, likely to be pregnant, or breastfeeding
Key Trial Info
Start Date :
July 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2029
Estimated Enrollment :
598 Patients enrolled
Trial Details
Trial ID
NCT06884332
Start Date
July 2 2025
End Date
January 2 2029
Last Update
September 23 2025
Active Locations (4)
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1
Centre Hospitalier Universitaire de Brest
Brest, Brest, France, 29609
2
Centre Henri Becquerel Rouen
Rouen, Rouen, France, 76038
3
Institut de cancérologie de l'Ouest (ICO)
Saint-Herblain, Saint-Herblain, France, 44805
4
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54511