Clinical trial · Interventional
Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
The SMART Trial: A Randomised Feasibility Study Comparing Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
NCT07772206CI-TRIAL-00122854SMARTnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases of a Malignant Tumor | — | UNRESOLVED | — |
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multifraction Radiotherapy (20 Gy in 5 #) | Radiation | — | UNRESOLVED |
| Single-Fraction Radiotherapy (8Gy x 1#) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single-Fraction Radiotherapy (SFRT)
- description
- 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.
- interventionNames
- Radiation: Single-Fraction Radiotherapy (8Gy x 1#)
- type
- ACTIVE_COMPARATOR
- label
- Multifraction Radiotherapy (MFRT)
- description
- 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.
- interventionNames
- Radiation: Multifraction Radiotherapy (20 Gy in 5 #)
Primary outcomes (5)
- measure
- Percentage of target sample recruited
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (8)
- RESULTMcDonald 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. PMID 26909305
- RESULTHird 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. PMID 19167840
- RESULTWesthoff 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. PMID 26281825
- RESULTBalajiSubramanian 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. PMID 34992882
- RESULTSahgal 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. PMID 34126044
- RESULTChow 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.