Bone Metastasis, Oncology Pain
Conditions
Keywords
Bone metastasis, Irradiation, Palliative, Analgesic
Brief 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.
Detailed description
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.
Interventions
RADIATIONSparing irradiation
For Sparing irradiation arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.
RADIATIONConventional spinal irradiation
For conventional spinal irradiation arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, phase III, multicenter, non-inferiority, randomized (1:1) therapeutic clinical trial with two arms, evaluating the efficacy and tolerance of targeted analgesic irradiation limited to the affected vertebrae.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with bone pain related to at least 1 or more bone metastases of spinal location, contiguous or not, cervical (excluding C1), thoracic, lumbar or sacral up to and including S2; a patient can be included even if he or she is irradiated concomitantly or not for analgesic purposes on another non-spinal bone metastatic site. Bone lesions are objective on an imaging examination less than 3 months old: CT and/or MRI and/or PET and/or bone scintigraphy; * Patient with at least moderate pain with EN ≥ 5; * Patient on analgesic drug treatment for at least 7 days or poor tolerance of analgesics; * Patient irradiated for palliative analgesic purposes. Post-cementoplasty irradiation is possible; an extension to the soft tissues is not a contraindication to inclusion; * Patient with a validated palliative bone irradiation plan: 8 Gy / 1 fr or 20 Gy / 5 fr; * Patient with planning only in static IMRT, arc therapy or helical tomotherapy; * Patient with a primary cancer or a haemopathy; * Patient currently undergoing or not a specific oncological systemic treatment, left to the discretion of the investigating physician; * Patient currently undergoing or not a treatment with bisphosphonates and denosumab, left to the discretion of the investigating physician; * WHO ≤ 2; * Patient with a life expectancy ≥ 3 months; * Patient able and agreeing to follow all study procedures in accordance with the protocol; * Patient having understood, signed and dated the consent form; * Patient affiliated to the social security system.
Exclusion criteria
* Pediatric patient; * Patient undergoing stereotaxic irradiation; * Patient undergoing oligometastatic disease; * Patient undergoing re-irradiation unless the dose is not limiting to OARs; * Patient treated with RT2D (conventional 2-dimensional radiotherapy) or RT3D (conventional 3-dimensional radiotherapy); * Patient with MESCC (metastatic epidural spinal cord compression) except for a Bilsky grade \< 1b; * Patient who does not have a means of responding to online questionnaires; * Patient and their entourage who cannot read or express themselves in French; * Visually impaired patient; * Patient already included in another therapeutic trial with an experimental molecule; * Persons deprived of liberty or under guardianship (including curatorship). * Pregnant woman, likely to be pregnant, or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy | From enrollment to the end of treatment at day 30 after the first irradiation. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of a remote monitoring tool on quality of life | From enrollment to the 30 days after the first irradiation session | Quality of life will be assessed using questionnaire EORTC QLQ-C15PAL ; the score scale is from 0 to 100. |
| Evaluation of Quality of life Bone Metastases Module | From enrollment to the 30 days after the first irradiation session | Quality of life will be assessed using questionnaires EORTC QLQ-Bone Metastases (BM)22. The score scale ranges from 0 to 100. |
| Level of adherence | From enrollment to 45 days after the first irradiation | 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. |
| Use of a remote monitoring tool | From enrollment to 45 days after the first irradiation | The handling of the digital tool will be assessed by the System Usability Scale (SUS).The score scale ranges from 0 to 100. |
| Patient satisfaction | From enrollment to 30 months after the first irradiation | Patient satisfaction will be measured according to the PACIC (Patient Assessment Chronic Illness Care) score. The total score ranges from 1 to 5. |
| Tolerance of Reducing the Volume of Palliative Bone Metastatic Irradiation | From enrollment to the 30 days after the first irradiation session | 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. |
| Rate of analgesic re-irradiation | From enrollment to 30 days after the first irradiation session and after 12 months | The administration of a supplementary dose of irradiation between Day 30 and Month 12 will be recorded |
| Correlation between dosimetric constraints for organs at risk (OARs) and the associated grade 0, 1, 2, and 3 acute toxicities | From enrollment to 12 months after the first irradiation session. | 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. |
| Construction of a Prognostic Score | From enrollment to 12 months after the first irradiation session. | 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. |
| Overall survival | From enrollment to 12 months after the first irradiation session. | Overall survival will be calculated as the time elapsed between the end of treatment and the date of death, from all causes. |
| Medical care patient satisfaction | From enrollment to 30 months after the first irradiation. | Patient satisfaction will be measured according the questionnaire concerning medical care (PEC). The score scale ranges from 0 to 100. |
Countries
France
Contacts
Primary ContactJean-Christophe JCF FAIVRE, MD.
Backup ContactAurélien LAMBERT, MD.
Outcome results
None listed