Actively Recruiting
Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
Led by Institut de Cancérologie de Lorraine · Updated on 2025-09-23
598
Participants Needed
4
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with bone pain related to one or more spinal bone metastases (cervical excluding C1, thoracic, lumbar, sacral up to S2) confirmed by imaging less than 3 months old
- At least moderate pain with a score of 5 or higher on the numeric scale
- On analgesic treatment for at least 7 days or intolerant to analgesics
- Planned for palliative spinal irradiation with 8 Gy in 1 fraction or 20 Gy in 5 fractions
- Radiation planned using static IMRT, arc therapy, or helical tomotherapy
- Has a primary cancer or hematologic malignancy
- May be receiving or not systemic oncological treatment, at physician's discretion
- May be receiving or not bisphosphonates or denosumab, at physician's discretion
- WHO performance status of 2 or less
- Life expectancy of at least 3 months
- Able and willing to follow all study procedures
- Has signed informed consent
- Affiliated to social security system
You will not qualify if you...
- Pediatric patient
- Receiving stereotaxic irradiation
- Having oligometastatic disease
- Undergoing re-irradiation with limiting dose to organs at risk
- Previously treated with conventional 2D or 3D radiotherapy
- Having metastatic epidural spinal cord compression except Bilsky grade less than 1b
- Without means to respond to online questionnaires
- Unable to read or express in French
- Visually impaired
- Already enrolled in another therapeutic trial with experimental drug
- Deprived of liberty or under guardianship
- Pregnant, likely pregnant, or breastfeeding
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Centre Hospitalier Universitaire de Brest
Brest, Brest, France, 29609
Actively Recruiting
2
Centre Henri Becquerel Rouen
Rouen, Rouen, France, 76038
Actively Recruiting
3
Institut de cancérologie de l'Ouest (ICO)
Saint-Herblain, Saint-Herblain, France, 44805
Actively Recruiting
4
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
Research Team
J
Jean-Christophe JCF FAIVRE, MD.
CONTACT
A
Aurélien LAMBERT, MD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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