[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499528":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":63,"responsibleParty":275,"collaborators":279,"id":286,"slug":36,"hasResults":287,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":36,"eligibilityCriteria":291,"healthyVolunteers":287,"sex":292,"minAge":293,"maxAge":36,"enrollmentInfo":294,"targetDuration":36,"studyType":297,"phases":298,"briefSummary":300,"conditions":301,"keywords":36,"overallStatus":66,"whyStopped":36,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},{"fullName":5,"class":6},"British Columbia Cancer Agency","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Multiple fraction SABR (Arm 1)","ACTIVE_COMPARATOR","Participants randomized to this arm will receive multiple fraction SABR",[13],"Radiation: Multiple fraction SABR",{"label":15,"type":16,"description":17,"interventionNames":18},"Single fraction SABR (Arm 2)","EXPERIMENTAL","Participants randomized to this arm will receive single fraction SABR",[19],"Radiation: Single fraction SABR",{"label":21,"type":10,"description":22,"interventionNames":23},"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).",[24],"Other: QoL reporting alone",{"label":26,"type":16,"description":27,"interventionNames":28},"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\n* Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment",[29],"Other: QoL reporting, symptom screen and healthcare provider intervention",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"RADIATION","Single fraction SABR","Participants randomized to this arm will receive SF SABR\n\nTreatment recommendations are as follows:\n\nLung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory OAR constraints are met: 30 Gy in 1 fraction\n\nLung: Within 2 cm of mediastinum or brachial plexus 20 Gy in 1 fraction\n\nBone, Spine, Adrenal, lymph node\u002Fsoft tissue: 20 Gy in 1 fraction\n\nLiver: 30 Gy in 1 fraction\n\nBrain: dose as per institutional policy",[15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Multiple fraction SABR","Participants randomized to this arm will receive MF SABR:\n\nDose\u002FFractionation are as follows:\n\nLung: 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\u002F#), 54 Gy in 3 fractions (18 Gy\u002F#), daily or every second day\n\nLung: Within 2 cm of mediastinum or brachial plexus 60 Gy in 8 fractions (7.5 Gy\u002F#), 50 Gy in 5 fractions (10 Gy\u002F#), daily\n\nBone: Any bone except spine: 35 Gy in 5 fractions (7 Gy\u002F#), daily\n\nLiver: 54 Gy in 3 fractions (18 Gy\u002F#) or 5 fractions (10.8 Gy\u002F#), daily or every second day\n\nSpine: 24 Gy in 2 fractions (12 Gy\u002F#) or 35 Gy in 5 fractions (7 Gy\u002F#), daily\n\nAdrenal: 40 Gy in 5 fractions (8 Gy\u002F#) or 35 Gy in 5 fractions (7 Gy\u002F#), daily\n\nLymph node\u002Fsoft tissue: 40 Gy in 5 fractions (8 Gy\u002F#) or 35 Gy in 5 fractions (7 Gy\u002F#), daily\n\nBrain - dose per institutional policy for stereotactic lesions (no whole brain RT).",[9],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"QoL reporting alone","Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit",[21],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"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.",[26],[50],{"name":51,"affiliation":52,"role":53},"Robert Olson, MD, MSc, FRCPC","BC Cancer - Prince George","PRINCIPAL_INVESTIGATOR",[55,60],{"name":56,"role":57,"phone":58,"phoneExt":36,"email":59},"Robert Olson, MD, MSC, FRCPC","CONTACT","250-645-7300","rolson2@bccancer.bc.ca",{"name":61,"role":57,"phone":58,"phoneExt":36,"email":62},"Jordanna Laing, MSc","jordanna.laing@bccancer.bc.ca",[64,82,98,110,122,136,154,170,189,205,219,232,249,262],{"facility":65,"status":66,"city":67,"state":68,"zip":36,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"BC Cancer","RECRUITING","Kelowna","British Columbia","Canada","CA",{"type":72,"coordinates":73},"Point",[74,75],-119.48568,49.88307,{"lat":75,"lon":74},[78],{"name":79,"role":57,"phone":80,"phoneExt":36,"email":81},"Benjamin Mou, MD","250-712-3900","benjamin.mou@bccancer.bc.ca",{"facility":65,"status":66,"city":83,"state":68,"zip":84,"country":69,"countryCode":70,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Prince George","V2M 7E9",{"type":72,"coordinates":86},[87,88],-122.75301,53.9166,{"lat":88,"lon":87},[91,94,96],{"name":92,"role":57,"phone":93,"phoneExt":36,"email":59},"Robert A Olson, MD","2506457300",{"name":95,"role":57,"phone":93,"phoneExt":36,"email":62},"Jordanna Laing",{"name":97,"role":53,"phone":36,"phoneExt":36,"email":36},"Robert A Olson",{"facility":65,"status":66,"city":99,"state":68,"zip":36,"country":69,"countryCode":70,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Surrey",{"type":72,"coordinates":101},[102,103],-122.82509,49.10635,{"lat":103,"lon":102},[106],{"name":107,"role":57,"phone":108,"phoneExt":36,"email":109},"Devin Schellenberg, MD","604-930-2098","dschellenberg@bccancer.bc.ca",{"facility":65,"status":66,"city":111,"state":68,"zip":36,"country":69,"countryCode":70,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Vancouver",{"type":72,"coordinates":113},[114,115],-123.11934,49.24966,{"lat":115,"lon":114},[118],{"name":119,"role":57,"phone":120,"phoneExt":36,"email":121},"Mitchell Liu, MD","6048776000","mliu@bccancer.bc.ca",{"facility":123,"status":124,"city":125,"state":68,"zip":36,"country":69,"countryCode":70,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"BC Cancer - Victoria","NOT_YET_RECRUITING","Victoria",{"type":72,"coordinates":127},[128,129],-123.35155,48.4359,{"lat":129,"lon":128},[132],{"name":133,"role":57,"phone":134,"phoneExt":36,"email":135},"Boris Valev, MD","250-519-5500","boris.valev@bccancer.bc.ca",{"facility":137,"status":66,"city":138,"state":139,"zip":140,"country":69,"countryCode":70,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Health Sciences North Research Institute","Greater Sudbury","Ontario","P3E 5J1",{"type":72,"coordinates":142},[143,144],-80.99001,46.49,{"lat":144,"lon":143},[147,152],{"name":148,"role":57,"phone":149,"phoneExt":150,"email":151},"Jessica Richer","705.522.6237","1922","jricher@hsnri.ca",{"name":153,"role":53,"phone":36,"phoneExt":36,"email":36},"Andrew Pearce",{"facility":155,"status":66,"city":156,"state":139,"zip":157,"country":69,"countryCode":70,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Princess Margaret Cancer Centre | University Health Network","Toronto","M5G 1X6",{"type":72,"coordinates":159},[160,161],-79.39864,43.70643,{"lat":161,"lon":160},[164,168],{"name":165,"role":57,"phone":166,"phoneExt":36,"email":167},"Yoona Shin","416-946-4558","yoona.shin@uhn.ca",{"name":169,"role":53,"phone":36,"phoneExt":36,"email":36},"Chiaojung Jillian Tsai",{"facility":171,"status":66,"city":172,"state":173,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"University Hospital Galway","Galway","Connacht","H91 YR71","Ireland","IE",{"type":72,"coordinates":178},[179,180],-9.05095,53.27245,{"lat":180,"lon":179},[183,187],{"name":184,"role":57,"phone":185,"phoneExt":36,"email":186},"Helen McLoughlin","091 542600","Helen.McLoughlin6@hse.ie",{"name":188,"role":53,"phone":36,"phoneExt":36,"email":36},"Ronan McDermott",{"facility":190,"status":66,"city":191,"state":191,"zip":192,"country":175,"countryCode":176,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"St. Luke's Radiation Oncology Network","Dublin","D06 E1C9",{"type":72,"coordinates":194},[195,196],-6.24889,53.33306,{"lat":196,"lon":195},[199,203],{"name":200,"role":57,"phone":201,"phoneExt":36,"email":202},"Roisin O'Maolalai","0035314065458","roisin.omaolalai@slh.ie",{"name":204,"role":53,"phone":36,"phoneExt":36,"email":36},"Lorna Keenan",{"facility":206,"status":66,"city":191,"state":207,"zip":208,"country":175,"countryCode":176,"cosmosGeoPoint":209,"geoPoint":211,"contacts":212},"Mater Private Hospital","Leinster","D07 WKW8",{"type":72,"coordinates":210},[195,196],{"lat":196,"lon":195},[213,217],{"name":214,"role":57,"phone":215,"phoneExt":36,"email":216},"Lisa Scahill","+353 (1) 8034831","lscahill@mater.ie",{"name":218,"role":53,"phone":36,"phoneExt":36,"email":36},"Daniel Cagney",{"facility":220,"status":66,"city":191,"state":207,"zip":221,"country":175,"countryCode":176,"cosmosGeoPoint":222,"geoPoint":224,"contacts":225},"Beacon Hospital","D18 AK68",{"type":72,"coordinates":223},[195,196],{"lat":196,"lon":195},[226,230],{"name":227,"role":57,"phone":228,"phoneExt":36,"email":229},"Roisin Conaty","353 1 293 6600","roisin.conaty@beaconhospital.ie",{"name":231,"role":53,"phone":36,"phoneExt":36,"email":36},"Alina Mihai",{"facility":233,"status":66,"city":234,"state":235,"zip":236,"country":175,"countryCode":176,"cosmosGeoPoint":237,"geoPoint":241,"contacts":242},"Cork University Hospital","Cork","Munster","T12 DC4A",{"type":72,"coordinates":238},[239,240],-8.47061,51.89797,{"lat":240,"lon":239},[243,247],{"name":244,"role":57,"phone":245,"phoneExt":36,"email":246},"Murtaza Gangardiwala","021 4234807","murtaza.gangardiwala@hse.ie",{"name":248,"role":53,"phone":36,"phoneExt":36,"email":36},"Aisling Barry",{"facility":250,"status":66,"city":234,"state":235,"zip":251,"country":175,"countryCode":176,"cosmosGeoPoint":252,"geoPoint":254,"contacts":255},"Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre","T12 DV56",{"type":72,"coordinates":253},[239,240],{"lat":240,"lon":239},[256,260],{"name":257,"role":57,"phone":258,"phoneExt":36,"email":259},"Erica Bennett","+353 21-486-11","bennette10@upmc.ie",{"name":261,"role":53,"phone":36,"phoneExt":36,"email":36},"Paul Kelly",{"facility":263,"status":66,"city":264,"state":235,"zip":265,"country":175,"countryCode":176,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"UPMC Whitfield Hospital - Waterford","Waterford","X91 DH9W",{"type":72,"coordinates":267},[268,269],-7.11194,52.25833,{"lat":269,"lon":268},[272,273],{"name":257,"role":57,"phone":36,"phoneExt":258,"email":259},{"name":274,"role":53,"phone":36,"phoneExt":36,"email":36},"Ciara Lyons",{"type":276,"investigatorFullName":277,"investigatorTitle":278,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Robert Olson","Radiation Oncologist",[280,282,284],{"name":281,"class":6},"London Regional Cancer Program, Canada",{"name":283,"class":6},"Tom Baker Cancer Centre",{"name":285,"class":6},"Princess Margaret Hospital, Canada","100499528",false,"NCT05784428","Single vs. Multiple Fraction Trial of Stereotactic Ablative Radiotherapy for Comprehensive Treatment of Oligometastases\u002FProgression","Single vs. Multiple Fraction Non-Inferiority Trial of Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligo-metastases\u002FProgression: SIMPLIFY-SABR-COMET","Inclusion Criteria:\n\n* 1-5 current oligometastatic or oligo-progressive lesions\n* Age 18 years or older\n* Able to provide informed consent\n* Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver\u002Ffamily\u002Ffriend\u002Fresearch staff using electronic methods after providing consent to email use.\n* Life expectancy \\> 6 months\n* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* 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\\])\n* A history and physical examination, including ECOG performance status, performed within 6 weeks prior to enrollment\n* 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\n* 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\n* 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.\n* 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.\n* 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\n* 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\n* Patient is judged able to:\n\n  * Maintain a stable position during therapy\n  * Tolerate immobilization device(s) that may be required to deliver SABR safely\n* Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date\n\nExclusion Criteria:\n\n* Uncontrolled concurrent malignant cancer\n* Lesion in femoral bone requiring surgical fixation\n* 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.\n* 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.\n* 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).\n* Current malignant pleural effusion\n* 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.\n* Inability to treat all sites of oligometastatic or oligoprogressive disease\n* Presence of brain metastases as the sole site of disease\n* Maximum size of 5 cm for lesions outside the brain, except:\n\n  * 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)\n* Any brain metastasis \\> 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded\n* Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed\n* Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of \\>12\n* Dominant brain metastasis requiring surgical decompression\n* Surgical resection of all metastases (i.e. no lesion available to be treated with SABR)\n* Complete response to systemic therapy, defined as the absence of visible disease on imaging\n* Pregnant or breast feeding","ALL","18 Years",{"count":295,"type":296},598,"ESTIMATED","INTERVENTIONAL",[299],"NA","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.",[302,303,304,305],"Oligometastatic Disease","Oligoprogression","Toxicity Due to Radiotherapy","Quality of Life","2026-06-23",{"date":308,"type":309},"2026-06-25","ACTUAL",{"date":311,"type":309},"2025-04-16",{"date":313,"type":296},"2035-05-30",{"name":277,"class":6},14]