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Sperimentazione a frazione singola o multipla della radioterapia ablativa stereotassica per il trattamento completo delle oligometastasi/progressione

22 settembre 2026 aggiornato da: Robert Olson

Sperimentazione di non inferiorità a frazione singola vs. multipla della radioterapia ablativa stereotassica per il trattamento completo delle oligometastasi/progressione: SIMPLIFY-SABR-COMET

Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Radiation can be delivered in multiple fractions, or doses, and can take up to several weeks or months of treatment depending on the type of cancer. Radiation can also be offered in a single fraction. Both techniques have evidence for use in clinical care. Multiple fraction is offered to reduce the amount of radiation given at a single time that could reduce late toxicities. However, single fraction radiotherapy is more cost-effective and saves patient time. With this trial, we will compare single fraction vs. multiple fraction in regards to their impact on toxicity, progression-free survival: time from randomization to disease progression at any site or death, lesional control rate: lesion size post-SABR, quality of life and cost-effectiveness.

In a subset of sites, we will also investigate the impact of healthcare-provider guided intervention on quality of life. Questionnaires capture various symptoms such as pain, fatigue and information relating to physical, social, and mental wellbeing. This information can help shed light on patient experience and provide a better understanding of the effects of radiation therapy. In this trial, we will compare quality of life questionnaire completion, symptom reporting and healthcare-provider guided intervention vs. quality of life questionnaire completion alone, in regards to patient quality of life. Hospitalization rates and frequency of emergency department visits will also be investigated.

Sample size: The total sample size of 598 for this trial was calculated based on the primary endpoint of toxicity for the single vs. multiple fraction SABR randomization. Calculations were performed based on the results of the SABR-5 trial and our clinical judgement.

Quality Assurance: Radiation treatments are based on the current phase III SABR-COMET-3 trial and as per recent clinical evidence. All treatments will be planned as per protocol including computed tomography (CT) simulation, organs at risk contouring and undergo a quality assurance process.

For the subset of sites involved in the second randomization, training will be provided to patients on the use of Noona, a patient-reported outcome platform.

Tipo di studio

Interventistico

Iscrizione (Stimato)

598

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

Backup dei contatti dello studio

Luoghi di studio

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Prince George, British Columbia, Canada, V2M 7E9
      • Surrey, British Columbia, Canada
      • Vancouver, British Columbia, Canada
        • Reclutamento
        • BC Cancer
        • Contatto:
      • Victoria, British Columbia, Canada
        • Non ancora reclutamento
        • BC Cancer - Victoria
        • Contatto:
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Reclutamento
        • Health Sciences North Research Institute
        • Investigatore principale:
          • Andrew Pearce
        • Contatto:
      • Toronto, Ontario, Canada, M5G 1X6
        • Reclutamento
        • Princess Margaret Cancer Centre | University Health Network
        • Investigatore principale:
          • Chiaojung Jillian Tsai
        • Contatto:
  • Irlanda
    • Connacht
      • Galway, Connacht, Irlanda, H91 YR71
        • Reclutamento
        • University Hospital Galway
        • Contatto:
        • Investigatore principale:
          • Ronan McDermott
    • Dublin
      • Dublin, Dublin, Irlanda, D06 E1C9
        • Reclutamento
        • St. Luke's Radiation Oncology Network
        • Contatto:
        • Investigatore principale:
          • Lorna Keenan
    • Leinster
      • Dublin, Leinster, Irlanda, D18 AK68
        • Reclutamento
        • Beacon Hospital
        • Contatto:
        • Investigatore principale:
          • Alina Mihai
      • Dublin, Leinster, Irlanda, D07 WKW8
        • Reclutamento
        • Mater Private Hospital
        • Contatto:
        • Investigatore principale:
          • Daniel Cagney
    • Munster
      • Cork, Munster, Irlanda, T12 DV56
        • Reclutamento
        • Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre
        • Investigatore principale:
          • Paul Kelly
        • Contatto:
      • Cork, Munster, Irlanda, T12 DC4A
        • Reclutamento
        • Cork University Hospital
        • Contatto:
        • Investigatore principale:
          • Aisling Barry
      • Waterford, Munster, Irlanda, X91 DH9W
        • Reclutamento
        • UPMC Whitfield Hospital - Waterford
        • Contatto:
        • Investigatore principale:
          • Ciara Lyons

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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • 1-5 current oligometastatic or oligo-progressive lesions

  • Age 18 years or older

  • Able to provide informed consent

  • Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver/family/friend/research staff using electronic methods after providing consent to email use.

  • Life expectancy > 6 months

  • Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging [e.g. primary unknown])

  • A history including ECOG performance status, performed within 6 weeks prior to enrollment

  • Patient has had a CT chest, abdomen and pelvis or PET-CT within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • Patient has had a nuclear bone scan (if no positron emission tomography-computed tomography [PET-CT]) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • Patient has had CT or MRI brain imaging if primary has a propensity for central nervous system metastases (if deemed appropriate by the treating investigator) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment.

  • For patients with known spine metastases, patient has had MRI spine imaging within 10 weeks prior to enrollment, and with 13 weeks prior to treatment.

  • If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG (fluorodeoxyglucose) PET scan or CT (chest, abdomen, pelvis) and bone scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • If colorectal primary with rising Carcinoembryonic antigen (CEA), but equivocal imaging, patient has had an FDG PET scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • Patient is judged able to:

    • Maintain a stable position during therapy
    • Tolerate immobilization device(s) that may be required to deliver SABR safely

  • Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date

Exclusion Criteria:

  • Uncontrolled concurrent malignant cancer

  • Lesion in femoral bone requiring surgical fixation

  • No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 1 week prior to radiation, lasting until 1 week after the last fraction. See section 5.3.3 regarding this criterion.

  • Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.

  • Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, similar biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with the local and study principal investigators (PIs).

  • Current malignant pleural effusion

  • Liver metastases located in the "Biliary no fly zone" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm.

  • Inability to treat all sites of oligometastatic or oligoprogressive disease (all lesions must be suitable for both single- and multi-fraction SABR)

  • Presence of brain metastases as the sole site of disease

  • Maximum size of 5 cm for lesions outside the brain, except:

    • Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)

  • Any brain metastasis > 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded

  • Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed

  • Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of >12

  • Dominant brain metastasis requiring surgical decompression

  • Surgical resection of all metastases (i.e. no lesion available to be treated with SABR)

  • Complete response to systemic therapy, defined as the absence of visible disease on imaging

  • Pregnant or breast feeding

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 fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Multiple fraction SABR (Arm 1)

Participants randomized to this arm will receive multiple fraction SABR
Radiazione: Multiple fraction SABR

Participants randomized to this arm will receive MF SABR:

Dose/Fractionation are as follows:

Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory organ-at-risk (OAR) constraints are met: 48 Gy in 4 fractions (12 Gy/#), 54 Gy in 3 fractions (18 Gy/#), daily or every second day

Lung: Within 2 cm of mediastinum or brachial plexus 60 Gy in 8 fractions (7.5 Gy/#), 50 Gy in 5 fractions (10 Gy/#), daily

Bone: Any bone except spine: 35 Gy in 5 fractions (7 Gy/#), daily

Liver: 54 Gy in 3 fractions (18 Gy/#) or 5 fractions (10.8 Gy/#), daily or every second day

Spine: 24 Gy in 2 fractions (12 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Adrenal: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Lymph node/soft tissue: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Brain - dose per institutional policy for stereotactic lesions (no whole brain RT).
Sperimentale: Single fraction SABR (Arm 2)

Participants randomized to this arm will receive single fraction SABR
Radiazione: Single fraction SABR

Participants randomized to this arm will receive SF SABR

Treatment recommendations are as follows:

Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory OAR constraints are met: 30 Gy in 1 fraction

Lung: Within 2 cm of mediastinum or brachial plexus 20 Gy in 1 fraction

Bone, Spine, Adrenal, lymph node/soft tissue: 20 Gy in 1 fraction

Liver: 30 Gy in 1 fraction

Brain: dose as per institutional policy
Comparatore attivo: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)

Participants will complete the EuroQoL-5Dimensions-5levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G) prior to each scheduled follow-up (FU).
Altro: QoL reporting alone

Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit
Sperimentale: QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)
  • Patients complete EQ-5D-5L and FACT-G prior to each scheduled FU
  • Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment
Altro: QoL reporting, symptom screen and healthcare provider intervention

Participants randomized to this arm will complete the FACT,G, EQ-5D-5L, radiation-symptom screen and receive healthcare provider-guided intervention based on their symptom reports.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adverse events
Lasso di tempo: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Occurrences and changes in grade 3 or higher adverse events related to treatment, according to CTCAE v5.0
At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change in patient-reported quality of life
Lasso di tempo: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

As measured by the EQ-5D-5L. This questionnaire provides measures for mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a numbered scale from 0 to 100 where 100 means the best health one can imagine, and 0 means the worst health one can imagine.
At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Lesional control rate
Lasso di tempo: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Rate is determined based on lesion size post-SABR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Progression-free survival
Lasso di tempo: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Time from randomization to disease progression at any site or death
At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Overall survival
Lasso di tempo: Approximately at the end of year 5 of follow-up, at study completion

Time from randomization to death from any cause (exploratory)
Approximately at the end of year 5 of follow-up, at study completion
Resource utilization
Lasso di tempo: At 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Assessed via patient- and provider-reported hospitalization rates, frequency of emergency department visits, number of patients with systemic or radiation therapy post SABR treatment on trial
At 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Robert Olson

Investigatori

  • Investigatore principale: Robert Olson, MD, MSc, FRCPC, BC Cancer - Prince George

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

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 (Effettivo)

16 aprile 2025

Completamento primario (Stimato)

30 aprile 2035

Completamento dello studio (Stimato)

30 maggio 2035

Date di iscrizione allo studio

Primo inviato

28 febbraio 2023

Primo inviato che soddisfa i criteri di controllo qualità

23 marzo 2023

Primo Inserito (Effettivo)

24 marzo 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • SIMPLIFY-SABR-COMET

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 .

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