Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut de Cancérologie de Lorraine
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
Pediatric patient;
Patient undergoing stereotaxic irradiation;
Patient undergoing oligometastatic disease;
Patient undergoing re-irradiation unless the dose is not limiting to OARs;
Trial design
Treatments tested in this trial
- Sparing irradiation
- Conventional spinal irradiation
Treatment groups
598 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov