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Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases (SMART)

14 augusti 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Oman
    • Muḩāfaz̧at Masqaţ
      • Muscat, Muḩāfaz̧at Masqaţ, Oman, 100
        • Royal Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Strålning: Single-Fraction Radiotherapy (8Gy x 1#)
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
Aktiv komparator: 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.
Strålning: Multifraction Radiotherapy (20 Gy in 5 #)
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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of target sample recruited
Tidsram: From study initiation through completion of the recruitment period.
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).
From study initiation through completion of the recruitment period.
Percentage of participants completing assigned radiotherapy
Tidsram: From randomisation through completion of assigned radiotherapy.
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).
From randomisation through completion of assigned radiotherapy.
Percentage of participants completing 3-month follow-up
Tidsram: From randomisation through 3 months after radiotherapy.
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).
From randomisation through 3 months after radiotherapy.
Percentage of participants with complete required study data
Tidsram: 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).
From study initiation through 3 months after radiotherapy.
Percentage of participants with major protocol deviations
Tidsram: From randomisation through 3 months after radiotherapy.
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).
From randomisation through 3 months after radiotherapy.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of participants achieving overall pain response at 4 weeks.
Tidsram: 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.
4 weeks after radiotherapy
Percentage of participants requiring retreatment
Tidsram: From completion of radiotherapy through 3 months after radiotherapy
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.
From completion of radiotherapy through 3 months after radiotherapy
Percentage of participants experiencing pain flare
Tidsram: 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.
From completion of radiotherapy through 10 days after radiotherapy.
Percentage of participants achieving overall pain response at 2 weeks and 3 months
Tidsram: 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.
2 weeks and 3 months after radiotherapy
Change in analgesic requirement from baseline
Tidsram: At 2 weeks, 4 weeks, and 3 months after radiotherapy
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.
At 2 weeks, 4 weeks, and 3 months after radiotherapy

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants receiving radiotherapy to new painful metastatic sites
Tidsram: From completion of radiotherapy through 3 months after radiotherapy
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.
From completion of radiotherapy through 3 months after radiotherapy

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Oman Ministry of Health

Samarbetspartners

Royal Hospital, Oman

Utredare

  • Huvudutredare: Balaji Subramanian Sitaraman, MBBS, DNB, Royal Hospital, Ministry of Health, Oman

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

30 december 2027

Studieregistreringsdatum

Först inskickad

8 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

14 augusti 2026

Första postat (Faktisk)

19 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MoH/CSR/26/32133

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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