Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More Institut de Cancérologie de Lorraine trials in France
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