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AzTrials

Oligometastatic DiseaseNCT05784428

Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases/Progression

A study testing Single fraction SABR, Multiple fraction SABR and QoL reporting alone in people with Oligometastatic Disease and Oligoprogression, run by Robert Olson at 14 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Single fraction SABR, Multiple fraction SABR and QoL reporting alone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
598 participants
Where
14 sitesin 2 countries
Study dates
16 Apr 2025to 30 May 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

14 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Robert Olson, MD, MSC, FRCPC contact

250-645-7300

rolson2@bccancer.bc.ca

Hadassah Abraham, MSc contact

250-645-7300

hadassah.abraham@bccancer.bc.ca

14 sites in 2 countries

Canada7 sites, 7 recruiting

  • Health Sciences North Research Institute

    Greater Sudbury, Ontario, P3E 5J1

    Jessica Richer, 705.522.6237 ext. 1922, jricher@hsnri.ca

    Andrew Pearce

    Recruiting

  • BC Cancer

    Kelowna, British Columbia

    Benjamin Mou, MD, 250-712-3900, benjamin.mou@bccancer.bc.ca

    Recruiting

  • BC Cancer

    Prince George, British Columbia, V2M 7E9

    Robert A Olson, MD, 2506457300, rolson2@bccancer.bc.ca

    Hadassah Abraham, 2506457300, hadassah.abraham@bccancer.bc.ca

    Recruiting

  • BC Cancer

    Surrey, British Columbia

    Devin Schellenberg, MD, 604-930-2098, dschellenberg@bccancer.bc.ca

    Recruiting

  • Princess Margaret Cancer Centre | University Health Network

    Toronto, Ontario, M5G 1X6

    Yoona Shin, 416-946-4558, yoona.shin@uhn.ca

    Chiaojung Jillian Tsai

    Recruiting

  • BC Cancer

    Vancouver, British Columbia

    Mitchell Liu, MD, 6048776000, mliu@bccancer.bc.ca

    Recruiting

  • BC Cancer - Victoria

    Victoria, British Columbia

    Boris Valev, MD, 250-519-5500, boris.valev@bccancer.bc.ca

    Not yet recruiting

Other trials in Canada

Ireland7 sites, 7 recruiting

  • Cork University Hospital

    Cork, Munster, T12 DC4A

    Murtaza Gangardiwala, 021 4234807, murtaza.gangardiwala@hse.ie

    Aisling Barry

    Recruiting

  • Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre

    Cork, Munster, T12 DV56

    Erica Bennett, +353 21-486-11, bennette10@upmc.ie

    Paul Kelly

    Recruiting

  • St. Luke's Radiation Oncology Network

    Dublin, Dublin, D06 E1C9

    Roisin O'Maolalai, 0035314065458, roisin.omaolalai@slh.ie

    Lorna Keenan

    Recruiting

  • Mater Private Hospital

    Dublin, Leinster, D07 WKW8

    Lisa Scahill, +353 (1) 8034831, lscahill@mater.ie

    Daniel Cagney

    Recruiting

  • Beacon Hospital

    Dublin, Leinster, D18 AK68

    Roisin Conaty, 353 1 293 6600, roisin.conaty@beaconhospital.ie

    Alina Mihai

    Recruiting

  • University Hospital Galway

    Galway, Connacht, H91 YR71

    Helen McLoughlin, 091 542600, Helen.McLoughlin6@hse.ie

    Ronan McDermott

    Recruiting

  • UPMC Whitfield Hospital - Waterford

    Waterford, Munster, X91 DH9W

    Erica Bennett, bennette10@upmc.ie

    Ciara Lyons

    Recruiting

Other trials in Ireland

About this study

Official title: Single vs. Multiple Fraction Non-Inferiority Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligo-metastases/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.

Read the detailed description

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.

Being tested
Single fraction SABR, Multiple fraction SABR, QoL reporting alone, QoL reporting, symptom screen and healthcare provider intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single fraction SABRRadiation

    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

  • Multiple fraction SABRRadiation

    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).

  • QoL reporting aloneOther

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

  • QoL reporting, symptom screen and healthcare provider interventionOther

    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.

Study groups in NCT05784428
Study groupRoleWhat they receive
Multiple fraction SABR (Arm 1)Active comparatorParticipants randomized to this arm will receive multiple fraction SABR
Receives: Radiation: Multiple fraction SABR
Single fraction SABR (Arm 2)ExperimentalParticipants randomized to this arm will receive single fraction SABR
Receives: Radiation: Single fraction SABR
Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)Active comparatorParticipants 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).
Receives: Other: QoL reporting alone
QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)Experimental* 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
Receives: Other: QoL reporting, symptom screen and healthcare provider intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Occurrences and changes in grade 3 or higher adverse events related to treatment, according to CTCAE v5.0

    Measured: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

  2. Change in patient-reported quality of life

    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.

    Measured: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Secondary outcomes (4)

  1. Lesional control rate

    Rate is determined based on lesion size post-SABR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Measured: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

  2. Progression-free survival

    Time from randomization to disease progression at any site or death

    Measured: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

  3. Overall survival

    Time from randomization to death from any cause (exploratory)

    Measured: Approximately at the end of year 5 of follow-up, at study completion

  4. Resource utilization

    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

    Measured: At 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2023
  2. Study start16 Apr 2025
  3. Primary completion30 Apr 2035 (estimated)
  4. Study completion30 May 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
This study is a phase III multicentre randomized trial. All participants will be randomized in a 1:1 ratio between multiple fraction SABR (Arm 1) vs. single fraction SABR (Arm 2). Patients will be stratified by systemic therapy within the last 2 weeks (yes/no); number of sites to be treated (1 vs. multiple) and SABR to the abdominal/pelvic site (yes/no). BC Cancer sites will also participate in the second randomization. Participants will be randomized in a 1:1 ratio to QoL reporting alone via FACT-G and EQ-5D-5L (Arm A) vs. QoL reporting and patient-reported outcome (PRO) symptom screen with healthcare provider intervention (Arm B). Patients will be further stratified by the criteria for the 1st randomization as as well as sex.
Masking
None (open label)
Enrolment
598 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784428
Sponsor's protocol ID
SIMPLIFY-SABR-COMET
Status last verified
Sep 2026
First submitted
28 Feb 2023
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.

    PubMed 7799047

  • Patel PH, Palma D, McDonald F, Tree AC. The Dandelion Dilemma Revisited for Oligoprogression: Treat the Whole Lawn or Weed Selectively? Clin Oncol (R Coll Radiol). 2019 Dec;31(12):824-833. doi: 10.1016/j.clon.2019.05.015. Epub 2019 Jun 8.

    PubMed 31182289

  • Nguyen TK, Chin L, Sahgal A, Dagan R, Eppinga W, Guckenberger M, Kim JH, Lo SS, Redmond KJ, Siva S, Stish BJ, Chan R, Lawrence L, Lau A, Tseng CL. International Multi-institutional Patterns of Contouring Practice and Clinical Target Volume Recommendations for Stereotactic Body Radiation Therapy for Non-Spine Bone Metastases. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):351-360. doi: 10.1016/j.ijrobp.2021.09.004. Epub 2021 Sep 9.

    PubMed 34509549

  • Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.

    PubMed 22608954

  • Redmond KJ, Robertson S, Lo SS, Soltys SG, Ryu S, McNutt T, Chao ST, Yamada Y, Ghia A, Chang EL, Sheehan J, Sahgal A. Consensus Contouring Guidelines for Postoperative Stereotactic Body Radiation Therapy for Metastatic Solid Tumor Malignancies to the Spine. Int J Radiat Oncol Biol Phys. 2017 Jan 1;97(1):64-74. doi: 10.1016/j.ijrobp.2016.09.014. Epub 2016 Sep 17.

    PubMed 27843035

  • Dunne EM, Sahgal A, Lo SS, Bergman A, Kosztyla R, Dea N, Chang EL, Chang UK, Chao ST, Faruqi S, Ghia AJ, Redmond KJ, Soltys SG, Liu MC. International consensus recommendations for target volume delineation specific to sacral metastases and spinal stereotactic body radiation therapy (SBRT). Radiother Oncol. 2020 Apr;145:21-29. doi: 10.1016/j.radonc.2019.11.026. Epub 2019 Dec 23.

    PubMed 31874346

  • Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

    PubMed 21479777

  • Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 2017

  • Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.

    PubMed 8445433

  • Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.

    PubMed 25265940

  • Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.

    PubMed 26644527

  • Olson R, Mathews L, Liu M, Schellenberg D, Mou B, Berrang T, Harrow S, Correa RJM, Bhat V, Pai H, Mohamed I, Miller S, Schneiders F, Laba J, Wilke D, Senthi S, Louie AV, Swaminath A, Chalmers A, Gaede S, Warner A, de Gruijl TD, Allan A, Palma DA. Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial. BMC Cancer. 2020 May 5;20(1):380. doi: 10.1186/s12885-020-06876-4.

    PubMed 32370765

  • Olson R, Abraham H, Leclerc C, Benny A, Baker S, Matthews Q, Chng N, Bergman A, Mou B, Dunne EM, Schellenberg D, Jiang W, Chan E, Atrchian S, Lefresne S, Carolan H, Valev B, Tyldesley S, Bang A, Berrang T, Clark H, Hsu F, Louie AV, Warner A, Palma DA, Howell D, Barry A, Dawson L, Grendarova P, Walker D, Sinha R, Tsai J, Bahig H, Thibault I, Koul R, Senthi S, Phillips I, Grose D, Kelly P, Armstrong J, McDermott R, Johnstone C, Vasan S, Aherne N, Harrow S, Liu M. Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET. BMC Cancer. 2024 Feb 3;24(1):171. doi: 10.1186/s12885-024-11905-7.

    PubMed 38310262

Questions about this trial

What is this clinical trial studying?

A study testing Single fraction SABR, Multiple fraction SABR and QoL reporting alone in people with Oligometastatic Disease and Oligoprogression, run by Robert Olson at 14 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Canada, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Robert Olson, MD, MSC, FRCPC (250-645-7300, rolson2@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05784428, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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