Targeted spinal radiation that spares adjacent vertebrae to treat pain from spinal bone metastases

Étude de Non infériorité Sur l'Impact de la Diminution Des Volumes d'Irradiations vertébraux en Cas d'Irradiation Palliative Rachidienne métastatique Osseuse Sur l'efficacité Antalgique

This project tests whether using smaller, targeted spinal radiation still relieves pain at 30 days for people with painful spinal bone metastases and whether telemonitoring can spot those who need extra care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 598 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut de Cancérologie de Lorraine (Academic / other)
• Drugs / interventions: denosumab
• Locations: 4 sites (Brest, Brest and 3 other locations)
• Trial ID: NCT06884332 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized, prospective two-arm study comparing standard palliative spinal irradiation (including adjacent vertebrae) with a volume-sparing approach that intentionally spares the vertebrae next to the painful lesion. Eligible patients have painful spinal bone metastases and receive standard palliative regimens (8 Gy in 1 fraction or 20 Gy in 5 fractions) planned with CT-based static IMRT, arc therapy, or helical tomotherapy. The primary outcome is analgesic effectiveness at day 30, and a secondary objective is to test telemonitoring of patient-reported outcomes to identify patients who need additional care. Sites in France enroll and randomize patients to determine whether reduced irradiated volume maintains pain control while limiting exposure of healthy tissue.

Who should consider this trial

Good fit: Adults with at least moderate pain (EN ≥ 5) from one or more spinal bone metastases (cervical excluding C1, thoracic, lumbar, or sacral up to S2), with recent imaging (CT/MRI/PET/bone scan within 3 months), on analgesics for ≥7 days or intolerant to analgesics, and planned for palliative RT of 8 Gy/1fr or 20 Gy/5fr using CT-based IMRT/arc/tomotherapy are ideal candidates.

Not a fit: Patients with metastases limited to non-spinal sites, lesions at excluded levels (C1), those who cannot undergo CT-based IMRT/arc/tomotherapy planning, who require different radiation regimens, or who cannot attend the participating centers or use telemonitoring are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, patients could get the same pain relief with less radiation to nearby healthy spine and potentially fewer side effects, while telemonitoring could lead to earlier supportive care when needed.

How similar studies have performed: Short-course palliative radiation reliably relieves bone pain in many trials, telemonitoring of patient-reported outcomes has shown benefits in oncology, and reducing margins with modern CT-based planning is a plausible but less-studied approach being tested here.

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

Where this trial is running

Brest, Brest and 3 other locations

• Centre Hospitalier Universitaire de Brest — Brest, Brest, France (Recruiting)
• Centre Henri Becquerel Rouen — Rouen, Rouen, France (Recruiting)
• Institut de cancérologie de l'Ouest (ICO) — Saint-Herblain, Saint-Herblain, France (Recruiting)
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (Recruiting)

Study contacts

• Study coordinator: Jean-Christophe JCF FAIVRE, MD.

Conditions Bone Metastasis; Oncology Pain; Bone metastasis; Irradiation; Palliative; Analgesic