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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: jc.faivre@nancy.unicancer.fr
• Phone: +33383594072

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.