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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional spinal irradiation | Active Comparator | Spinal irradiation without sparing the adjacent vertebrae. |
|
| Sparing irradiation | Experimental | Spinal irradiation while sparing the adjacent vertebrae. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sparing irradiation | Radiation | For "Sparing irradiation" arm the Clinical Target Volume (CTV) = Growth Tumor Volume (GTV) + entire vertebra opposite. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the 30 days after the first irradiation session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Christophe JCF FAIVRE, MD. | Contact | +33383594072 | 4072 | jc.faivre@nancy.unicancer.fr |
| Aurélien LAMBERT, MD. | Contact | +33383594123 | 4123 | a.lambert@nancy.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nour MAMMARI HALABI, PhD. | Institut de Cancérologie de Lorraine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Brest | Recruiting | Brest | Brest | 29609 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20818875 | Result | 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. | |
| 20562730 | Result | 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. |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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. |
|
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | From enrollment to 12 months after the first irradiation session. |
| Centre Henri Becquerel Rouen | Recruiting | Rouen | Rouen | 76038 | France |
|
| Institut de cancérologie de l'Ouest (ICO) | Recruiting | Saint-Herblain | Saint-Herblain | 44805 | France |
|
| Institut de Cancérologie de Lorraine | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
|
| 30231381 | Result | 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. |
| 33362171 | Result | 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. |
| 17081915 | Result | 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. |
| 25624439 | Result | 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. |
| 11683656 | Result | 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. |
| 20220181 | Result | 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. |
| 858248 | Result | 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. |
| 21074335 | Result | 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. |
| 38788923 | Result | 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. |
| 35661676 | Result | 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. |
| 21489705 | Result | 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. |