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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Sparing irradiation
RadiationFor "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.
Conventional spinal irradiation
RadiationFor "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.
Treatment groups
598 Participants
are divided into 2 treatment groupsGroup A: Conventional spinal irradiationActive comparator 1 intervention
Group B: Sparing irradiationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy
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.
Time frame
From enrollment to the end of treatment at day 30 after the first irradiation.Secondary outcomes
1
Tolerance of Reducing the Volume of Palliative Bone Metastatic Irradiation
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.
Time frame
From enrollment to the 30 days after the first irradiation session2
Impact of a remote monitoring tool on quality of life
Quality of life will be assessed using questionnaire EORTC QLQ-C15PAL ; the score scale is from 0 to 100.
Time frame
From enrollment to the 30 days after the first irradiation session3
Evaluation of Quality of life Bone Metastases Module
Quality of life will be assessed using questionnaires EORTC QLQ-Bone Metastases (BM)22. The score scale ranges from 0 to 100.
Time frame
From enrollment to the 30 days after the first irradiation session4
Level of adherence
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.
Time frame
From enrollment to 45 days after the first irradiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov