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New treatment option for Bone Metastasis
Official title Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
ClinicalTrials.gov ID: NCT06884332
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with bone pain related to at least 1 or more bone metastases of spinal location, contiguous or not, cervical (excluding C1), thoracic, lumbar...
- 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...
- Patient with a validated palliative bone irradiation plan: 8 Gy / 1 fr or 20 Gy / 5 fr;
You likely can't join if
- 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;
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brest, Brest, France
- Rouen, Rouen, France
- Saint-Herblain, Saint-Herblain, France
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brest, Brest, France; Rouen, Rouen, France; Saint-Herblain, Saint-Herblain, France; Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.