Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality
NCT ID: NCT06884332
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
598 participants
INTERVENTIONAL
2025-07-02
2029-01-02
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional spinal irradiation
Spinal irradiation without sparing the adjacent vertebrae.
Conventional spinal irradiation
For "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.
Sparing irradiation
Spinal irradiation while sparing the adjacent vertebrae.
Sparing irradiation
For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.
Interventions
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Sparing irradiation
For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.
Conventional spinal irradiation
For "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut de Cancérologie de Lorraine
OTHER
Responsible Party
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Principal Investigators
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Nour MAMMARI HALABI, PhD.
Role: STUDY_CHAIR
Institut de Cancérologie de Lorraine
Locations
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Centre Hospitalier Universitaire de Brest
Brest, Brest, France
Centre Henri Becquerel Rouen
Rouen, Rouen, France
Institut de cancérologie de l'Ouest (ICO)
Saint-Herblain, Saint-Herblain, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Fisher 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.
Basch 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.
Marino 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.
Basch 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.
Di 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.
Stromgren 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.
Basch 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.
Del 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.
Klish 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.
Alcorn 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.
van 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.
Chow 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.
Other Identifiers
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2024-A02789-38
Identifier Type: -
Identifier Source: org_study_id
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