Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases (SMART)
14 agosto 2026 aggiornato da: Balaji Subramanian Sitaraman, Oman Ministry of Health
The SMART Trial: A Randomised Feasibility Study Comparing Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
This prospective randomised pilot feasibility study will compare single-fraction radiotherapy (8 Gy × 1) with multifraction radiotherapy (20 Gy in 5 fractions) for the palliation of painful bone metastases.
The study will evaluate pain response at 4 weeks following radiotherapy, together with feasibility, treatment compliance, toxicity, pain flare, retreatment, patient convenience and resource utilisation.
The study will generate preliminary data to inform the design of a future definitive randomised trial.
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
Single-fraction radiotherapy (SFRT) is an established standard treatment for palliation of painful bone metastases. However, multifraction radiotherapy (MFRT) continues to be widely used in clinical practice because of concerns regarding durability of pain control and retreatment. With the increasing use of modern arc-based radiotherapy techniques such as volumetric modulated arc therapy (VMAT), there is a need to evaluate whether single-fraction radiotherapy can provide effective pain palliation while reducing treatment burden and improving resource utilisation.
The SMART trial is a prospective, single-centre, randomised, open-label, parallel-group pilot feasibility study comparing VMAT-based SFRT (8 Gy in 1 fraction) with VMAT-based MFRT (20 Gy in 5 fractions) in patients with painful bone metastases, including spinal metastases.
Approximately 70 participants will be randomised in a 1:1 ratio to receive either SFRT or MFRT. Both treatment schedules will be delivered using VMAT with daily image-guided radiotherapy using cone-beam computed tomography (CBCT)-based image guidance.
Stratified block randomisation will be used according to the site of metastasis (spine versus non-spine) to maintain balance between the two treatment groups. Within each stratum, computer-generated variable block randomisation using block sizes of 4 and 6 will be used. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes.
Pain will be assessed using the Numeric Rating Scale (NRS-11) and Wong-Baker FACES Pain Scale at baseline and during follow-up. Participants will be assessed at 2 weeks, 4 weeks and 12 weeks after radiotherapy.
The primary aim of this pilot study is to assess the feasibility of conducting a randomised controlled trial at the participating tertiary oncology centre. Feasibility will include recruitment, treatment completion, follow-up completion and completeness of study data.
The primary efficacy outcome will be overall pain response at 4 weeks following radiotherapy. Secondary outcomes will include pain response at other follow-up time points, retreatment rates, pain flare, treatment-related toxicity, patient convenience and resource utilisation.
The study is not powered to provide a definitive non-inferiority conclusion. A non-inferiority margin of 15% has been prespecified to guide estimation of the treatment effect and inform the design and sample size of a future definitive randomised trial. The primary efficacy analysis will compare overall pain response between the two treatment groups using the intention-to-treat population.
The study will generate preliminary feasibility and clinical outcome data to inform the design of a future definitive randomised controlled trial evaluating single-fraction versus multifraction radiotherapy for painful bone metastases.
Tipo di studio
Interventistico
Iscrizione (Stimato)
70
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Balaji Subramanian Sitaraman, MBBS, DNB
- Numero di telefono: +96871926769
- Email: balaji.radonc@gmail.com
Luoghi di studio
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Muḩāfaz̧at Masqaţ
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Muscat, Muḩāfaz̧at Masqaţ, Oman, 100
- Royal Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- Age ≥18 years
- Histologically proven malignancy
- Radiological evidence of bone or spine metastases
- Pain score ≥4 on Numeric Rating Scale (NRS-11)
- ECOG Performance Status 0-3
- Life expectancy ≥3 months.
- Ability to provide written informed consent
Exclusion Criteria:
- Spinal cord compression requiring emergency therapy
- Previous radiotherapy to same site
- Unstable pathological fracture requiring surgery
- Pregnancy
- Inability to provide consent
- Oligometastatic bone metastases requiring Stereotactic Body Radiotherapy (SBRT)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Single-Fraction Radiotherapy (SFRT)
Participants will receive VMAT-basd radiotherapy to painful none metastasis, a total dose of 8 Gy delivered in a single fraction using CBCT based imaging guidance.
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VMAT-based external beam radiotherapy planned to deliver 8 Gy in a single fraction with CBCT-based image guidance for the palliation of painful bone metastasis
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Comparatore attivo: Multifraction Radiotherapy (MFRT)
Participants will receive VMAT-basd radiotherapy to painful none metastasis, a total dose of 20Gy delivered in Five fractions using daily CBCT based imaging guidance.
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VMAT-based external beam radiotherapy planned to deliver 20 Gy in Five fractions of 4 Gy each with daily CBCT-based image guidance for the palliation of painful bone metastasis
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of target sample recruited
Lasso di tempo: From study initiation through completion of the recruitment period.
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The percentage of the planned target sample successfully recruited during the recruitment period.
Recruitment feasibility will be interpreted using predefined traffic-light criteria: Green ≥80% (feasibility achieved), Amber 70-79% (borderline feasibility requiring review), and Red <70% (feasibility not achieved and requiring review).
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From study initiation through completion of the recruitment period.
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Percentage of participants completing assigned radiotherapy
Lasso di tempo: From randomisation through completion of assigned radiotherapy.
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The percentage of randomised participants who complete the assigned radiotherapy treatment according to the study protocol.
Treatment completion feasibility will be interpreted using predefined traffic-light criteria: Green ≥90% (feasibility achieved), Amber 80-89% (borderline feasibility requiring review), and Red <80% (feasibility not achieved and requiring review).
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From randomisation through completion of assigned radiotherapy.
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Percentage of participants completing 3-month follow-up
Lasso di tempo: From randomisation through 3 months after radiotherapy.
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The percentage of randomised participants who complete the required study follow-up through 3 months after radiotherapy.
Follow-up feasibility will be interpreted using predefined traffic-light criteria: Green ≥80% (feasibility achieved), Amber 70-79% (borderline feasibility requiring review), and Red <70% (feasibility not achieved and requiring review).
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From randomisation through 3 months after radiotherapy.
|
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Percentage of participants with complete required study data
Lasso di tempo: From study initiation through 3 months after radiotherapy.
|
The percentage of participants with complete required study data according to the study data collection requirements.
Data completeness will be interpreted using predefined traffic-light criteria: Green ≥90% (feasibility achieved), Amber 80-89% (borderline feasibility requiring review), and Red <80% (feasibility not achieved and requiring review).
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From study initiation through 3 months after radiotherapy.
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Percentage of participants with major protocol deviations
Lasso di tempo: From randomisation through 3 months after radiotherapy.
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The percentage of participants with major protocol deviations during the study.
A major protocol deviation is a significant departure from the study protocol that may affect participant safety, treatment allocation, assessment of the primary outcome, or validity of the study results.
Protocol adherence will be interpreted using predefined traffic-light criteria: Green <10% major protocol deviations (feasibility achieved), Amber 10-20% (borderline feasibility requiring review), and Red >20% (feasibility not achieved and requiring review).
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From randomisation through 3 months after radiotherapy.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Percentage of participants achieving overall pain response at 4 weeks.
Lasso di tempo: 4 weeks after radiotherapy
|
Overall pain response will be assessed using the NRS-11 and analgesic use.
Pain response is defined as a reduction of at least 2 points in pain from baseline with no escalation in analgesic use.
The percentage of participants achieving pain response will be compared between the SFRT and MFRT groups.
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4 weeks after radiotherapy
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Percentage of participants requiring retreatment
Lasso di tempo: From completion of radiotherapy through 3 months after radiotherapy
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The percentage of participants requiring repeat radiotherapy to the treated sitefor persisten or recurrence of pain will be recorded and compared between the SFRT and MFRT groups.
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From completion of radiotherapy through 3 months after radiotherapy
|
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Percentage of participants experiencing pain flare
Lasso di tempo: From completion of radiotherapy through 10 days after radiotherapy.
|
Pain flare following radiotherapy will be recorded and compared between the SFRT and MFRT groups.
Pain flare is defined as increase in NRS pain score by ≥2 points without reduction in analgesic use, or Increase in analgesic requirement by ≥25% without improvement in pain score, followed by return to the baseline pain level or analgesic requirement within 10 days after radiotherapy.
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From completion of radiotherapy through 10 days after radiotherapy.
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Percentage of participants achieving overall pain response at 2 weeks and 3 months
Lasso di tempo: 2 weeks and 3 months after radiotherapy
|
Overall pain response will be assessed using the NRS-11 and analgesic use.
Pain response is defined as a reduction of at least 2 points in pain from baseline with no escalation in analgesic use.
The percentage of participants achieving pain response will be recorded at 2 weeks and 3 months after radiotherapy and compared between the SFRT and MFRT groups.
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2 weeks and 3 months after radiotherapy
|
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Change in analgesic requirement from baseline
Lasso di tempo: At 2 weeks, 4 weeks, and 3 months after radiotherapy
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Change in analgesic requirement from baseline will be assessed using the patient's analgesic consumption and expressed as oral morphine equivalent dose (OMED).
The change in analgesic requirement will be recorded and compared between the SFRT and MFRT groups.
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At 2 weeks, 4 weeks, and 3 months after radiotherapy
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of participants receiving radiotherapy to new painful metastatic sites
Lasso di tempo: From completion of radiotherapy through 3 months after radiotherapy
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The number of participants who receive radiotherapy to new painful metastatic sites during the 3-month follow-up period will be recorded descriptively.
This outcome reflects the occurrence of new painful metastatic disease during follow-up and is not intended to assess the efficacy of SFRT versus MFRT.
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From completion of radiotherapy through 3 months after radiotherapy
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Balaji Subramanian Sitaraman, MBBS, DNB, Royal Hospital, Ministry of Health, Oman
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
- Sahgal A, Myrehaug SD, Siva S, Masucci GL, Maralani PJ, Brundage M, Butler J, Chow E, Fehlings MG, Foote M, Gabos Z, Greenspoon J, Kerba M, Lee Y, Liu M, Liu SK, Thibault I, Wong RK, Hum M, Ding K, Parulekar WR; trial investigators. Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial. Lancet Oncol. 2021 Jul;22(7):1023-1033. doi: 10.1016/S1470-2045(21)00196-0. Epub 2021 Jun 11.
- McDonald R, Chow E, Lam H, Rowbottom L, Soliman H. International patterns of practice in radiotherapy for bone metastases: A review of the literature. J Bone Oncol. 2014 Nov 7;3(3-4):96-102. doi: 10.1016/j.jbo.2014.10.003. eCollection 2014 Nov.
- Hird A, Chow E, Zhang L, Wong R, Wu J, Sinclair E, Danjoux C, Tsao M, Barnes E, Loblaw A. Determining the incidence of pain flare following palliative radiotherapy for symptomatic bone metastases: results from three canadian cancer centers. Int J Radiat Oncol Biol Phys. 2009 Sep 1;75(1):193-7. doi: 10.1016/j.ijrobp.2008.10.044. Epub 2009 Jan 23.
- Westhoff PG, de Graeff A, Monninkhof EM, Pomp J, van Vulpen M, Leer JW, Marijnen CA, van der Linden YM; Dutch Bone Metastasis Study Group. Quality of Life in Relation to Pain Response to Radiation Therapy for Painful Bone Metastases. Int J Radiat Oncol Biol Phys. 2015 Nov 1;93(3):694-701. doi: 10.1016/j.ijrobp.2015.06.024. Epub 2015 Jun 20.
- BalajiSubramanian S, Sathiya K, Balaji K, Thirunavukarasu M, Phanikiran S, Rela M. Re-irradiation after stereotactic body radiotherapy for spine metastases from hepatocellular carcinoma: a case report. Rep Pract Oncol Radiother. 2021 Dec 30;26(6):1060-1065. doi: 10.5603/RPOR.a2021.0098. eCollection 2021.
- Chow E, Zeng L, Salvo N, Dennis K, Tsao M, Lutz S. Update on the systematic review of palliative radiotherapy trials for bone metastases. Clin Oncol (R Coll Radiol). 2012 Mar;24(2):112-24. doi: 10.1016/j.clon.2011.11.004. Epub 2011 Nov 29.
- Steenland E, Leer JW, van Houwelingen H, Post WJ, van den Hout WB, Kievit J, de Haes H, Martijn H, Oei B, Vonk E, van der Steen-Banasik E, Wiggenraad RG, Hoogenhout J, Warlam-Rodenhuis C, van Tienhoven G, Wanders R, Pomp J, van Reijn M, van Mierlo I, Rutten E. The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study. Radiother Oncol. 1999 Aug;52(2):101-9. doi: 10.1016/s0167-8140(99)00110-3.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 dicembre 2027
Completamento dello studio (Stimato)
30 dicembre 2027
Date di iscrizione allo studio
Primo inviato
8 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 agosto 2026
Primo Inserito (Effettivo)
19 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
19 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MoH/CSR/26/32133
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be routinely shared with other researchers.
The study is a single-center feasibility study, and the collected data will be used for the approved study objectives and institutional research purposes.
Any data sharing, if required in the future, will be considered in accordance with institutional policies, ethical approval, participant confidentiality, and applicable regulations.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .