Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality

Launched by INSTITUT DE CANCÉROLOGIE DE LORRAINE · Mar 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how reducing the amount of radiation given to patients with bone pain from cancer can still provide effective pain relief while also reducing side effects. The researchers want to compare two groups of patients: one group will receive standard spinal radiation treatment, while the other group will have radiation treatment that spares the nearby vertebrae. The goal is to see if patients can still manage their pain effectively with less radiation. Additionally, they will use telemonitoring to help identify patients who may need more support based on their reported pain levels and other health outcomes.

To participate in this trial, patients should be adults aged 65 and older who have moderate to severe bone pain from at least one cancer-related bone metastasis in the spine. They should also be receiving pain medication and have a life expectancy of at least three months. Participants will need to agree to follow the study procedures and will be monitored closely throughout the trial. It’s important to note that the trial is not yet recruiting participants, so those interested will need to wait for further announcements about when they can join.

Gender

ALL

Eligibility criteria

• 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