Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases (SMART)
2026年8月14日 更新者：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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
70
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Balaji Subramanian Sitaraman, MBBS, DNB
- 電話番号：+96871926769
- メール：balaji.radonc@gmail.com
研究場所
-
-
Muḩāfaz̧at Masqaţ
-
Muscat、Muḩāfaz̧at Masqaţ、オマーン、100
- Royal Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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
|
|
アクティブコンパレータ：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.
|
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of target sample recruited
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of participants achieving overall pain response at 4 weeks.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants receiving radiotherapy to new painful metastatic sites
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Balaji Subramanian Sitaraman, MBBS, DNB、Royal Hospital, Ministry of Health, Oman
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年12月1日
研究の完了 (推定)
2027年12月30日
試験登録日
最初に提出
2026年8月8日
QC基準を満たした最初の提出物
2026年8月14日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月14日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MoH/CSR/26/32133
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。