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Recruiting Not applicable

Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality

NCT06884332 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-07-02
Last updated
2025-09-23

Condition(s) studied

Bone MetastasisOncology Pain

Investigational drug(s) / intervention(s)

Sparing irradiationConventional spinal irradiation

Sparing irradiation: For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.

Conventional spinal irradiation: For "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy — From enrollment to the end of treatment at day 30 after the first irradiation.
    Pain response at day 30 at the site of the irradiated lesion will be assessed according to the international consensus definitions on bone metastases, using a numerical scale (0 to 10) and the consumption of equivalent opioids.

Trial sites (4)

FacilityCityRegionStatus
Centre Hospitalier Universitaire de Brest Brest Brest Recruiting
Centre Henri Becquerel Rouen Rouen Rouen Recruiting
Institut de cancérologie de l'Ouest (ICO) Saint-Herblain Saint-Herblain Recruiting
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06884332 on ClinicalTrials.gov ↗ ← All trials in France