protocolSection identificationModule nctId: NCT06356779, orgStudyIdInfo id: H-23066725, briefTitle: Longitudinal Study of Local Ablative Therapy in Oligometastatic Disease, acronym: OLIGO-DK, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2030-12-31, completionDateStruct date: 2035-12-31, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Gitte Fredberg Persson MD PhD, class: OTHER, descriptionModule briefSummary: This prospective national multicenter observational and interventional study aims to assess the longitudinal disease trajectory of patients with oligometastatic disease (OMD) who receive local metastasis-directed therapy. Patients with any category of OMD from any non-hematological cancer are eligible for inclusion. Local ablative therapy (LAT) includes surgical metastasectomy, radiotherapy, thermal ablation, and electroporations.The primary objective is to assess the time to failure of LAT strategy in patients with OMD from any primary cancer treated with all LAT modalities., conditionsModule conditions: Oligometastatic Disease, conditions: Metastases, conditions: Ablation Techniques, conditions: Radiotherapy, conditions: Stereotactic Radiation, conditions: Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1200, type: ESTIMATED, armsInterventionsModule interventions name: Local ablative therapy (LAT), outcomesModule primaryOutcomes measure: Time to failure of local ablative therapy (LAT) strategy, secondaryOutcomes measure: Progression-free survival, secondaryOutcomes measure: Time to widespread progression, secondaryOutcomes measure: Freedom from systemic treatment, secondaryOutcomes measure: Overall survival, secondaryOutcomes measure: Time to progression, secondaryOutcomes measure: Time to local progression, secondaryOutcomes measure: Local lesion control rate at 1- and 3-years post-local ablative therapy, secondaryOutcomes measure: Time to distant progression, secondaryOutcomes measure: Investigator reported grade 3-5 CTCAE (v.5.0) LAT related toxicity, secondaryOutcomes measure: Harms, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Copenhagen University Hospital Rigshospitalet, status: NOT_YET_RECRUITING, city: Copenhagen, state: Capital Region Of Denmark, zip: 2100, country: Denmark, contacts name: Mette Pøhl, MD PhD, role: CONTACT, contacts name: Mette Pøhl, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Maja Maraldo, MD PhD, role: SUB_INVESTIGATOR, contacts name: Morten Suppli, MD PhD, role: SUB_INVESTIGATOR, contacts name: Rene H Petersen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Hans-Christian Pommergaard, MD PhD, role: SUB_INVESTIGATOR, contacts name: Søren Møller, MD PhD, role: SUB_INVESTIGATOR, contacts name: Michael Achiam, MD PhD, role: SUB_INVESTIGATOR, contacts name: Mikkel Rosendahl, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.67594, lon: 12.56553, locations facility: Copenhagen University Hospital Herlev and Gentofte, status: RECRUITING, city: Herlev, state: Capital Region Of Denmark, zip: 2730, country: Denmark, contacts name: Michael RT Laursen, MD, role: CONTACT, phone: +453868 9202, email: michael.ruben.teindl.laursen@regionh.dk, contacts name: Mette Felter, MD PhD, role: SUB_INVESTIGATOR, contacts name: Henriette Lindberg, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Eva Serup-Hansen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Sebastian Krog, MD, role: SUB_INVESTIGATOR, contacts name: Jesper Palshof, MD PhD, role: SUB_INVESTIGATOR, contacts name: Bodil Engelmann, MD PhD, role: SUB_INVESTIGATOR, contacts name: Eva Ellebæk, MD PhD, role: SUB_INVESTIGATOR, contacts name: Lisbet Hölmich, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.72366, lon: 12.43998, locations facility: Hillerød Hospital, status: NOT_YET_RECRUITING, city: Hillerød, state: Capital Region Of Denmark, zip: 3400, country: Denmark, contacts name: Maria Lendorf, role: CONTACT, contacts name: Maria Lendorf, MD PD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.92791, lon: 12.30081, locations facility: Aarhus University Hospital, status: NOT_YET_RECRUITING, city: Aarhus, state: Central Denmark Region, zip: 8200, country: Denmark, contacts name: Mette Marie Fode, MD PhD, role: CONTACT, email: mettfode@rm.dk, contacts name: Mette Marie Fode, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Azza Khalil, MD PhD, role: SUB_INVESTIGATOR, contacts name: Thomas Decker Christensen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Ole Graumann, MD PhD, role: SUB_INVESTIGATOR, contacts name: Jørgen Bjerggaard Jensen, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Gødstrup Hospital, status: NOT_YET_RECRUITING, city: Herning, state: Central Denmark Region, zip: 7400, country: Denmark, contacts name: Trine Øllegaard, role: CONTACT, contacts name: Trine Øllegaard, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.13932, lon: 8.97378, locations facility: Danish Center for Particle Therapy, status: NOT_YET_RECRUITING, city: Aarhus, state: Central Region Denmark, zip: 8200, country: Denmark, contacts name: Britte Weber, MD PhD, role: CONTACT, contacts name: Britta Weber, MD PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 56.15674, lon: 10.21076, locations facility: Aalborg University Hospital, status: NOT_YET_RECRUITING, city: Aalborg, state: Northern Region Of Denmark, zip: 9000, country: Denmark, contacts name: Jimmy Søndergaard, MD PhD, role: CONTACT, contacts name: Laurids Ø Poulsen, MD PhD, role: CONTACT, contacts name: Jimmi Søndergaard, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Laurids Ø Poulsen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Hella Sand, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 57.048, lon: 9.9187, locations facility: Odense University Hospital, status: NOT_YET_RECRUITING, city: Odense, state: Southern Denmark Region, zip: 5000, country: Denmark, contacts name: Tine Schytte, MD PhD, role: CONTACT, contacts name: Tine Schytte, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Jørgen Johansen, MD PhD, role: SUB_INVESTIGATOR, contacts name: Christina Nyborg, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.39594, lon: 10.38831, locations facility: Sønderborg Hospital, status: NOT_YET_RECRUITING, city: Sønderborg, state: Southern Denmark Region, zip: 6400, country: Denmark, geoPoint lat: 54.90896, lon: 9.78924, locations facility: Vejle Hospital, status: NOT_YET_RECRUITING, city: Vejle, state: Southern Denmark Region, zip: 7100, country: Denmark, contacts name: Charlotte Kristiansen, MD, role: CONTACT, contacts name: Charlotte Kristiansen, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lars Fokdal, MD PhD, role: SUB_INVESTIGATOR, contacts name: Lise Bentzen, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 55.70927, lon: 9.5357, locations facility: Zealand University Hospital, Roskilde and Næstved, status: NOT_YET_RECRUITING, city: Roskilde, state: Zealand Region, zip: 4000, country: Denmark, contacts name: Julie Gehl, MD DMSc, role: CONTACT, contacts name: Julie Gehl, MD DMSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.64152, lon: 12.08035, hasResults: False