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RECRUITING
NCT06884332
NA

Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality

Sponsor: Institut de Cancérologie de Lorraine

View on ClinicalTrials.gov

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

Interventions

RADIATION

Sparing irradiation

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

RADIATION

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