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Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
Sponsor: Institut de Cancérologie de Lorraine
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.
Official title: Étude de Non infériorité Sur l'Impact de la Diminution Des Volumes d'Irradiations vertébraux en Cas d'Irradiation Palliative Rachidienne métastatique Osseuse Sur l'efficacité Antalgique
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
598
Start Date
2025-07-02
Completion Date
2029-01-02
Last Updated
2025-09-23
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
Centre Hospitalier Universitaire de Brest
Brest, Brest, France
Centre Henri Becquerel Rouen
Rouen, Rouen, France
Institut de cancérologie de l'Ouest (ICO)
Saint-Herblain, Saint-Herblain, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France