Spinal Palliation in Irradiation for Neoplastic Analgesia and Life Quality

NCT06884332 | Recruiting DMC

• 1 other identifier: 2024-A02789-38
• Study Type: interventional
• Target: 598
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Bone Metastasis; Oncology Pain

Keywords

Bone metastasis; Irradiation; Palliative; Analgesic

Outcome Measures

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.

  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

  From enrollment to the 30 days after the first irradiation session

• Impact of a remote monitoring tool on quality of life

  From enrollment to the 30 days after the first irradiation session

• Evaluation of Quality of life Bone Metastases Module

  From enrollment to the 30 days after the first irradiation session

• Level of adherence

  From enrollment to 45 days after the first irradiation

• Use of a remote monitoring tool

  From enrollment to 45 days after the first irradiation

Study Arms (2)

Conventional spinal irradiation

ACTIVE COMPARATOR

Spinal irradiation without sparing the adjacent vertebrae.

Radiation: Conventional spinal irradiation

Sparing irradiation

EXPERIMENTAL

Spinal irradiation while sparing the adjacent vertebrae.

Radiation: Sparing irradiation

Interventions

Sparing irradiation RADIATION

For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite.

Sparing irradiation

Conventional spinal irradiation RADIATION

For "conventional spinal irradiation" arm, Clinical Target Volume (CTV ) = Growth Tumor Volume (GTV) + entire vertebra opposite + 1 vertebra above and below.

Conventional spinal irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 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.

You may not qualify 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;
• 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

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (4)

Centre Hospitalier Universitaire de Brest

Brest, Brest, 29609, France

RECRUITING

Centre Henri Becquerel Rouen

Rouen, Rouen, 76038, France

RECRUITING

Institut de cancérologie de l'Ouest (ICO)

Saint-Herblain, Saint-Herblain, 44805, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (13)

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  PMID: 20818875 BACKGROUND

• 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.

  PMID: 20562730 BACKGROUND

• 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.

  PMID: 30231381 BACKGROUND

• 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.

  PMID: 33362171 BACKGROUND

• 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.

  PMID: 17081915 BACKGROUND

• 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.

  PMID: 25624439 BACKGROUND

• 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.

  PMID: 11683656 BACKGROUND

• 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.

  PMID: 20220181 BACKGROUND

• 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.

  PMID: 858248 BACKGROUND

• 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.

  PMID: 21074335 BACKGROUND

• 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.

  PMID: 38788923 BACKGROUND

• 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.

  PMID: 35661676 BACKGROUND

• 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.

  PMID: 21489705 BACKGROUND

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nour MAMMARI HALABI, PhD.

  Institut de Cancérologie de Lorraine

  STUDY CHAIR

Central Study Contacts

Jean-Christophe JCF FAIVRE, MD.

CONTACT

+33383594072; jc.faivre@nancy.unicancer.fr

Aurélien LAMBERT, MD.

CONTACT

+33383594123; a.lambert@nancy.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 19, 2025
• Study Start: July 2, 2025
• Primary Completion (Estimated): July 2, 2027
• Study Completion (Estimated): January 2, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)