An interventional study of Sparing irradiation and Conventional spinal irradiation in Bone Metastasis and Oncology Pain, sponsored by Institut de Cancérologie de Lorraine. Recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Treatment
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.
Palliative analgesic radiotherapy (RT) is used to relieve pain in patients with bone metastases. This technique involves irradiating the vertebrae above and below the ones responsible for the pain. Traditional two-dimensional radiotherapy (2D-RT) was characterized by a physical penumbra that could extend up to 50% of a vertebra's height, leading to underdosing of the target volume and, consequently, reduced analgesic effectiveness.
However, computed tomography (CT) scans or CT-based imaging have replaced these practices, allowing for high precision in delineating target volumes. Despite advancements in irradiation techniques, the physical penumbra is now negligible with modern machines, reducing the need for large margins and thereby limiting side effects associated with the irradiation of healthy tissues.
These factors have led us to conduct a clinical trial to assess the impact of reducing the volume of palliative metastatic bone irradiation on analgesic effectiveness at day 30 (D30) and to evaluate the efficiency of telemonitoring in identifying patients who could benefit from Patient-PROs and require care.
These objectives will be pursued 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. This could lead to changes in current palliative radiotherapy practices, reduce toxicity risks, and improve patients' quality of life.
310 studies on the registry are indexed under Cancer Pain; 73 are open to participants now.
This study's planned enrollment of 598 is above the median of 62 across 235 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Institut de Cancérologie de Lorraine is the lead sponsor of 62 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Spinal irradiation without sparing the adjacent vertebrae.
Radiation: Conventional spinal irradiation
Spinal irradiation while sparing the adjacent vertebrae.
Radiation: Sparing irradiation
For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.
For "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.
Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy
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.
Time frame: From enrollment to the end of treatment at day 30 after the first irradiation.
Tolerance of Reducing the Volume of Palliative Bone Metastatic Irradiation
Tolerance will be assessed by the occurrence of toxicities according to the National Cancer Institute (NCI) PRO-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: From enrollment to the 30 days after the first irradiation session
Impact of a remote monitoring tool on quality of life
Quality of life will be assessed using questionnaire EORTC QLQ-C15PAL ; the score scale is from 0 to 100.
Time frame: From enrollment to the 30 days after the first irradiation session
Evaluation of Quality of life Bone Metastases Module
Quality of life will be assessed using questionnaires EORTC QLQ-Bone Metastases (BM)22. The score scale ranges from 0 to 100.
Time frame: From enrollment to the 30 days after the first irradiation session
Level of adherence
The level of adherence will be assessed based on the rate of compliance with completing the online questionnaires by the patient or their caregivers. The score scale ranges from 0 to 100.
Time frame: From enrollment to 45 days after the first irradiation
Use of a remote monitoring tool
The handling of the digital tool will be assessed by the System Usability Scale (SUS).The score scale ranges from 0 to 100.
Time frame: From enrollment to 45 days after the first irradiation
Patient satisfaction
Patient satisfaction will be measured according to the PACIC (Patient Assessment Chronic Illness Care) score. The total score ranges from 1 to 5.
Time frame: From enrollment to 30 months after the first irradiation
Medical care patient satisfaction
Patient satisfaction will be measured according the questionnaire concerning medical care (PEC). The score scale ranges from 0 to 100.
Time frame: From enrollment to 30 months after the first irradiation.
Rate of analgesic re-irradiation
The administration of a supplementary dose of irradiation between Day 30 and Month 12 will be recorded
Time frame: From enrollment to 30 days after the first irradiation session and after 12 months
Correlation between dosimetric constraints for organs at risk (OARs) and the associated grade 0, 1, 2, and 3 acute toxicities
Doses to OARs will be collected for the main organs at risk (OARs) in the vicinity by exporting the dose-volume histograms for each organ at risk.
Time frame: From enrollment to 12 months after the first irradiation session.
Construction of a Prognostic Score
A prognostic score will be constructed from the variables of all the prognostic factors collected in this study. The score scale ranges from 0 to 100.
Time frame: From enrollment to 12 months after the first irradiation session.
Overall survival
Overall survival will be calculated as the time elapsed between the end of treatment and the date of death, from all causes.
Time frame: From enrollment to 12 months after the first irradiation session.
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.
Of 72 non-industry interventional studies with no phase under Cancer Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 24 months is above that.
Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 40.
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Institut de Cancérologie de Lorraine