Bone MetastasisSPINALNCT06884332
Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
A study testing Sparing irradiation and Conventional spinal irradiation in people with Bone Metastasis and Oncology Pain, run by Institut de Cancérologie de Lorraine at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastasis, Oncology Pain
- What is being tested?
- Sparing irradiation and Conventional spinal irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 598 participants
- Where
- 4 sitesFrance
- Study dates
- 2 Jul 2025to 2 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 14Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Centre Hospitalier Universitaire de Brest
Brest, Brest, 29609
BOURBONNE BV Vincent, MD., vincent.bourbonne@chu-brest.fr
LUCIA LF François, MD., +332982233, francois.lucia@chu-brest.fr
- Recruiting
Centre Henri Becquerel Rouen
Rouen, Rouen, 76038
THUREAU TS Sébastien, PR, +33232082992, sebastien.thureau@chb.unicancer.fr
THUREAU TS Sébastien, MD
- Recruiting
Institut de cancérologie de l'Ouest (ICO)
Saint-Herblain, Saint-Herblain, 44805
TOMASZEWSKI TF Florine, MD., +33240679919, Florine.Tomaszewski@ico.unicancer.fr
SUPIOT SS Stéphane, PR, stephane.supiot@ico.unicancer.fr
- Recruiting
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511
Jean-Louis JL MERLIN, PU., +33383598307 ext. 8307, jl.merlin@nancy.unicancer.fr
FAIVRE JCF Jean-Christophe, MD., +33383594072, jc.faivre@nancy.unicancer.fr
About this study
Official title: 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
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.
Read the detailed description
Palliative analgesic radiotherapy (RT) is used to relieve pain in patients with bone metastases. This technique involves irradiating the vertebrae above and below the ones responsible for the pain. Traditional two-dimensional radiotherapy (2D-RT) was characterized by a physical penumbra that could extend up to 50% of a vertebra's height, leading to underdosing of the target volume and, consequently, reduced analgesic effectiveness.
However, computed tomography (CT) scans or CT-based imaging have replaced these practices, allowing for high precision in delineating target volumes. Despite advancements in irradiation techniques, the physical penumbra is now negligible with modern machines, reducing the need for large margins and thereby limiting side effects associated with the irradiation of healthy tissues.
These factors have led us to conduct a clinical trial to assess the impact of reducing the volume of palliative metastatic bone irradiation on analgesic effectiveness at day 30 (D30) and to evaluate the efficiency of telemonitoring in identifying patients who could benefit from Patient-PROs and require care.
These objectives will be pursued 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. This could lead to changes in current palliative radiotherapy practices, reduce toxicity risks, and improve patients' quality of life.
- Conditions
- Bone Metastasis, Oncology Pain
- Being tested
- Sparing irradiation, Conventional spinal irradiation
- Keywords
- Bone metastasis, Irradiation, Palliative, Analgesic
- Medical subject headings
- Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparing irradiationRadiation
For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.
Conventional spinal irradiationRadiation
For "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.
| Study group | Role | What they receive |
|---|---|---|
| Conventional spinal irradiation | Active comparator | Spinal irradiation without sparing the adjacent vertebrae. Receives: Radiation: Conventional spinal irradiation |
| Sparing irradiation | Experimental | Spinal irradiation while sparing the adjacent vertebrae. Receives: Radiation: Sparing irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at day 30 after the first irradiation.
Secondary outcomes (11)
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.
Measured: From enrollment to the 30 days after the first irradiation session
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.
Measured: From enrollment to the 30 days after the first irradiation session
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.
Measured: From enrollment to the 30 days after the first irradiation session
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.
Measured: From enrollment to 45 days after the first irradiation
Use of a remote monitoring tool
The handling of the digital tool will be assessed by the System Usability Scale (SUS).The score scale ranges from 0 to 100.
Measured: From enrollment to 45 days after the first irradiation
Patient satisfaction
Patient satisfaction will be measured according to the PACIC (Patient Assessment Chronic Illness Care) score. The total score ranges from 1 to 5.
Measured: From enrollment to 30 months after the first irradiation
Medical care patient satisfaction
Patient satisfaction will be measured according the questionnaire concerning medical care (PEC). The score scale ranges from 0 to 100.
Measured: From enrollment to 30 months after the first irradiation.
Rate of analgesic re-irradiation
The administration of a supplementary dose of irradiation between Day 30 and Month 12 will be recorded
Measured: From enrollment to 30 days after the first irradiation session and after 12 months
Correlation between dosimetric constraints for organs at risk (OARs) and the associated grade 0, 1, 2, and 3 acute toxicities
Doses to OARs will be collected for the main organs at risk (OARs) in the vicinity by exporting the dose-volume histograms for each organ at risk.
Measured: From enrollment to 12 months after the first irradiation session.
Construction of a Prognostic Score
A prognostic score will be constructed from the variables of all the prognostic factors collected in this study. The score scale ranges from 0 to 100.
Measured: From enrollment to 12 months after the first irradiation session.
Overall survival
Overall survival will be calculated as the time elapsed between the end of treatment and the date of death, from all causes.
Measured: From enrollment to 12 months after the first irradiation session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start2 Jul 2025
- Primary completion2 Jul 2027 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, phase III, multicenter, non-inferiority, randomized (1:1) therapeutic clinical trial with two arms, evaluating the efficacy and tolerance of targeted analgesic irradiation limited to the affected vertebrae.
- Masking
- None (open label)
- Enrolment
- 598 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nour MAMMARI HALABI, PhD., Study chair, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884332
- Sponsor's protocol ID
- 2024-A02789-38
- Acronym
- SPINAL
- Status last verified
- Sep 2025
- First submitted
- 3 Mar 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
PubMed 20818875Fisher CG, DiPaola CP, Ryken TC, Bilsky MH, Shaffrey CI, Berven SH, Harrop JS, Fehlings MG, Boriani S, Chou D, Schmidt MH, Polly DW, Biagini R, Burch S, Dekutoski MB, Ganju A, Gerszten PC, Gokaslan ZL, Groff MW, Liebsch NJ, Mendel E, Okuno SH, Patel S, Rhines LD, Rose PS, Sciubba DM, Sundaresan N, Tomita K, Varga PP, Vialle LR, Vrionis FD, Yamada Y, Fourney DR. A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group. Spine (Phila Pa 1976). 2010 Oct 15;35(22):E1221-9. doi: 10.1097/BRS.0b013e3181e16ae2.
PubMed 20562730Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient-Reported Outcomes in Routine Medical Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:122-134. doi: 10.1200/EDBK_200383.
PubMed 30231381Marino D, Baratelli C, Guida G, Turco CGC, Lacidogna G, Sperti E, Vignani F, De Luca E, Zichi C, Audisio M, Ballaminut D, Bellezza A, Chiotto P, Ciriolo G, Comite R, Codegone F, Florio S, Fusco L, Polimeno L, Pozzi D, Zilio E, Terzolo S, Di Maio M. Impact of adoption of patient-reported outcomes in clinical practice on the accuracy of symptom reporting in medical records of cancer patients. Recenti Prog Med. 2020 Dec;111(12):740-748. doi: 10.1701/3509.34965.
PubMed 33362171Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
PubMed 17081915Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015 Mar 10;33(8):910-5. doi: 10.1200/JCO.2014.57.9334. Epub 2015 Jan 26.
PubMed 25624439Stromgren AS, Groenvold M, Sorensen A, Andersen L. Symptom recognition in advanced cancer. A comparison of nursing records against patient self-rating. Acta Anaesthesiol Scand. 2001 Oct;45(9):1080-5. doi: 10.1034/j.1399-6576.2001.450905.x.
PubMed 11683656Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 Mar 11;362(10):865-9. doi: 10.1056/NEJMp0911494. No abstract available.
PubMed 20220181Del Gaudio AC, Carpenter PJ, Stein LS, Morrow G. Characteristics of patients completing referrals from an emergency department to a psychiatric outpatient clinic. Compr Psychiatry. 1977 May-Jun;18(3):301-7. doi: 10.1016/0010-440x(77)90026-8. No abstract available.
PubMed 858248Klish DS, Grossman P, Allen PK, Rhines LD, Chang EL. Irradiation of spinal metastases: should we continue to include one uninvolved vertebral body above and below in the radiation field? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1495-9. doi: 10.1016/j.ijrobp.2010.07.2007. Epub 2010 Nov 11.
PubMed 21074335Alcorn S, Cortes AA, Bradfield L, Brennan M, Dennis K, Diaz DA, Doung YC, Elmore S, Hertan L, Johnstone C, Jones J, Larrier N, Lo SS, Nguyen QN, Tseng YD, Yerramilli D, Zaky S, Balboni T. External Beam Radiation Therapy for Palliation of Symptomatic Bone Metastases: An ASTRO Clinical Practice Guideline. Pract Radiat Oncol. 2024 Sep-Oct;14(5):377-397. doi: 10.1016/j.prro.2024.04.018. Epub 2024 May 22.
PubMed 38788923van der Velden J, Willmann J, Spalek M, Oldenburger E, Brown S, Kazmierska J, Andratschke N, Menten J, van der Linden Y, Hoskin P. ESTRO ACROP guidelines for external beam radiotherapy of patients with uncomplicated bone metastases. Radiother Oncol. 2022 Aug;173:197-206. doi: 10.1016/j.radonc.2022.05.024. Epub 2022 May 31.
PubMed 35661676Chow E, Hoskin P, Mitera G, Zeng L, Lutz S, Roos D, Hahn C, van der Linden Y, Hartsell W, Kumar E; International Bone Metastases Consensus Working Party. Update of the international consensus on palliative radiotherapy endpoints for future clinical trials in bone metastases. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1730-7. doi: 10.1016/j.ijrobp.2011.02.008. Epub 2011 Apr 12.
PubMed 21489705
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06884332
- Acronym / sponsor ID
- SPINAL / 2024-A02789-38
- Conditions
- Bone Metastasis, Oncology Pain
- Keywords
- Bone metastasis, Irradiation, Palliative, Analgesic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 598 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Palliative analgesic radiotherapy (RT) is used to relieve pain in patients with bone metastases. This technique involves irradiating the vertebrae above and below the ones responsible for the pain. Traditional two-dimensional radiotherapy (2D-RT) was characterized by a physical penumbra that could extend up to 50% of a vertebra's height, leading to underdosing of the target volume and, consequently, reduced analgesic effectiveness.
However, computed tomography (CT) scans or CT-based imaging have replaced these practices, allowing for high precision in delineating target volumes. Despite advancements in irradiation techniques, the physical penumbra is now negligible with modern machines, reducing the need for large margins and thereby limiting side effects associated with the irradiation of healthy tissues.
These factors have led us to conduct a clinical trial to assess the impact of reducing the volume of palliative metastatic bone irradiation on analgesic effectiveness at day 30 (D30) and to evaluate the efficiency of telemonitoring in identifying patients who could benefit from Patient-PROs and require care.
These objectives will be pursued 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. This could lead to changes in current palliative radiotherapy practices, reduce toxicity risks, and improve patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, phase III, multicenter, non-inferiority, randomized (1:1) therapeutic clinical trial with two arms, evaluating the efficacy and tolerance of targeted analgesic irradiation limited to the affected vertebrae.
| Arm | Type | Receives |
|---|---|---|
| Conventional spinal irradiation | Active comparator | Radiation: Conventional spinal irradiationSpinal irradiation without sparing the adjacent vertebrae. |
| Sparing irradiation | Experimental | Radiation: Sparing irradiationSpinal irradiation while sparing the adjacent vertebrae. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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;
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparing irradiationFor "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite. | Radiation | Sparing irradiation |
| Conventional spinal irradiationFor "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below. | Radiation | Conventional spinal irradiation |
Primary outcome
Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy
Time frame: From enrollment to the end of treatment at day 30 after the first irradiation.
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.
11 secondary outcomes
Tolerance of Reducing the Volume of Palliative Bone Metastatic Irradiation
Time frame: From enrollment to the 30 days after the first irradiation session
Impact of a remote monitoring tool on quality of life
Time frame: From enrollment to the 30 days after the first irradiation session
Evaluation of Quality of life Bone Metastases Module
Time frame: From enrollment to the 30 days after the first irradiation session
Level of adherence
Time frame: From enrollment to 45 days after the first irradiation
Use of a remote monitoring tool
Time frame: From enrollment to 45 days after the first irradiation
Patient satisfaction
Time frame: From enrollment to 30 months after the first irradiation
Medical care patient satisfaction
Time frame: From enrollment to 30 months after the first irradiation.
Rate of analgesic re-irradiation
Time frame: From enrollment to 30 days after the first irradiation session and after 12 months
Correlation between dosimetric constraints for organs at risk (OARs) and the associated grade 0, 1, 2, and 3 acute toxicities
Time frame: From enrollment to 12 months after the first irradiation session.
Construction of a Prognostic Score
Time frame: From enrollment to 12 months after the first irradiation session.
Overall survival
Time frame: From enrollment to 12 months after the first irradiation session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Results publication: PubMed 20818875Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, Dahlin CM, Blinderman CD, Jacobsen J, Pirl WF, Billings JA, Lynch TJ. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010 Aug 19;363(8):733-42. doi: 10.1056/NEJMoa1000678.
- Results publication: PubMed 20562730Fisher CG, DiPaola CP, Ryken TC, Bilsky MH, Shaffrey CI, Berven SH, Harrop JS, Fehlings MG, Boriani S, Chou D, Schmidt MH, Polly DW, Biagini R, Burch S, Dekutoski MB, Ganju A, Gerszten PC, Gokaslan ZL, Groff MW, Liebsch NJ, Mendel E, Okuno SH, Patel S, Rhines LD, Rose PS, Sciubba DM, Sundaresan N, Tomita K, Varga PP, Vialle LR, Vrionis FD, Yamada Y, Fourney DR. A novel classification system for spinal instability in neoplastic disease: an evidence-based approach and expert consensus from the Spine Oncology Study Group. Spine (Phila Pa 1976). 2010 Oct 15;35(22):E1221-9. doi: 10.1097/BRS.0b013e3181e16ae2.
- Results publication: PubMed 30231381Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient-Reported Outcomes in Routine Medical Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:122-134. doi: 10.1200/EDBK_200383.
- Results publication: PubMed 33362171Marino D, Baratelli C, Guida G, Turco CGC, Lacidogna G, Sperti E, Vignani F, De Luca E, Zichi C, Audisio M, Ballaminut D, Bellezza A, Chiotto P, Ciriolo G, Comite R, Codegone F, Florio S, Fusco L, Polimeno L, Pozzi D, Zilio E, Terzolo S, Di Maio M. Impact of adoption of patient-reported outcomes in clinical practice on the accuracy of symptom reporting in medical records of cancer patients. Recenti Prog Med. 2020 Dec;111(12):740-748. doi: 10.1701/3509.34965.
- Results publication: PubMed 17081915Basch E, Iasonos A, McDonough T, Barz A, Culkin A, Kris MG, Scher HI, Schrag D. Patient versus clinician symptom reporting using the National Cancer Institute Common Terminology Criteria for Adverse Events: results of a questionnaire-based study. Lancet Oncol. 2006 Nov;7(11):903-9. doi: 10.1016/S1470-2045(06)70910-X.
- Results publication: PubMed 25624439Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, Gridelli C, Gebbia V, Ciardiello F, De Placido S, Ceribelli A, Favaretto AG, de Matteis A, Feld R, Butts C, Bryce J, Signoriello S, Morabito A, Rocco G, Perrone F. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015 Mar 10;33(8):910-5. doi: 10.1200/JCO.2014.57.9334. Epub 2015 Jan 26.
- Results publication: PubMed 11683656Stromgren AS, Groenvold M, Sorensen A, Andersen L. Symptom recognition in advanced cancer. A comparison of nursing records against patient self-rating. Acta Anaesthesiol Scand. 2001 Oct;45(9):1080-5. doi: 10.1034/j.1399-6576.2001.450905.x.
- Results publication: PubMed 20220181Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010 Mar 11;362(10):865-9. doi: 10.1056/NEJMp0911494. No abstract available.
- Results publication: PubMed 858248Del Gaudio AC, Carpenter PJ, Stein LS, Morrow G. Characteristics of patients completing referrals from an emergency department to a psychiatric outpatient clinic. Compr Psychiatry. 1977 May-Jun;18(3):301-7. doi: 10.1016/0010-440x(77)90026-8. No abstract available.
- Results publication: PubMed 21074335Klish DS, Grossman P, Allen PK, Rhines LD, Chang EL. Irradiation of spinal metastases: should we continue to include one uninvolved vertebral body above and below in the radiation field? Int J Radiat Oncol Biol Phys. 2011 Dec 1;81(5):1495-9. doi: 10.1016/j.ijrobp.2010.07.2007. Epub 2010 Nov 11.
- Results publication: PubMed 38788923Alcorn S, Cortes AA, Bradfield L, Brennan M, Dennis K, Diaz DA, Doung YC, Elmore S, Hertan L, Johnstone C, Jones J, Larrier N, Lo SS, Nguyen QN, Tseng YD, Yerramilli D, Zaky S, Balboni T. External Beam Radiation Therapy for Palliation of Symptomatic Bone Metastases: An ASTRO Clinical Practice Guideline. Pract Radiat Oncol. 2024 Sep-Oct;14(5):377-397. doi: 10.1016/j.prro.2024.04.018. Epub 2024 May 22.
- Results publication: PubMed 35661676van der Velden J, Willmann J, Spalek M, Oldenburger E, Brown S, Kazmierska J, Andratschke N, Menten J, van der Linden Y, Hoskin P. ESTRO ACROP guidelines for external beam radiotherapy of patients with uncomplicated bone metastases. Radiother Oncol. 2022 Aug;173:197-206. doi: 10.1016/j.radonc.2022.05.024. Epub 2022 May 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nour MAMMARI HALABI, PhD. study chair
Institut de Cancérologie de Lorraine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparing irradiation and Conventional spinal irradiation in people with Bone Metastasis and Oncology Pain, run by Institut de Cancérologie de Lorraine at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe JCF FAIVRE, MD. (+33383594072 ext. 4072, jc.faivre@nancy.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Reducing the Volume of Palliative Bone Metastatic Irradiation on Analgesic Efficacy (time frame: From enrollment to the end of treatment at day 30 after the first irradiation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06884332, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.