NCT06884332 Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
| NCT ID | NCT06884332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut de Cancérologie de Lorraine |
| Condition | Bone Metastasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 598 participants |
| Start Date | 2025-07-02 |
| Primary Completion | 2027-07-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 598 participants in total. It began in 2025-07-02 with a primary completion date of 2027-07-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
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 form; * Patient affiliated to the social security system. Exclusion Criteria: * 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
Contact & Investigator
Nour MAMMARI HALABI, PhD.
STUDY CHAIR
Institut de Cancérologie de Lorraine
Frequently Asked Questions
Who can join the NCT06884332 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Metastasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06884332 currently recruiting?
Yes, NCT06884332 is actively recruiting participants. Contact the research team at jc.faivre@nancy.unicancer.fr for enrollment information.
Where is the NCT06884332 trial being conducted?
This trial is being conducted at Brest, France, Rouen, France, Saint-Herblain, France, Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT06884332 clinical trial?
NCT06884332 is sponsored by Institut de Cancérologie de Lorraine. The principal investigator is Nour MAMMARI HALABI, PhD. at Institut de Cancérologie de Lorraine. The trial plans to enroll 598 participants.