Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Enkelt vs. multiple fraktionsforsøg med stereootaktisk ablativ strålebehandling til omfattende behandling af oligometastaser/progression

22. september 2026 opdateret af: Robert Olson

Enkelt vs. Multiple Fraktion Non-Inferioritetsundersøgelse af stereootaktisk ablativ strålebehandling til omfattende behandling af oligometastaser/progression: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

598

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Multiple fraction SABR (Arm 1)

Participants randomized to this arm will receive multiple fraction SABR
Stråling: 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).
Eksperimentel: Single fraction SABR (Arm 2)

Participants randomized to this arm will receive single fraction SABR
Stråling: 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
Aktiv komparator: 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).
Andet: QoL reporting alone

Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit
Eksperimentel: 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
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse events
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lesional control rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Robert Olson

Efterforskere

  • Ledende efterforsker: Robert Olson, MD, MSc, FRCPC, BC Cancer - Prince George

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. april 2025

Primær færdiggørelse (Anslået)

30. april 2035

Studieafslutning (Anslået)

30. maj 2035

Datoer for studieregistrering

Først indsendt

28. februar 2023

Først indsendt, der opfyldte QC-kriterier

23. marts 2023

Først opslået (Faktiske)

24. marts 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • SIMPLIFY-SABR-COMET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner