Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
NCT06884332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 598
Last updated 2025-09-23
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.
Conditions
- Bone Metastasis
- Oncology Pain
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.
Sponsors & Collaborators
-
Institut de Cancérologie de Lorraine
lead OTHER
Principal Investigators
-
Nour MAMMARI HALABI, PhD. · Institut de Cancérologie de Lorraine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-02
- Primary Completion
- 2027-07-02
- Completion
- 2029-01-02
Countries
- France
Study Locations
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