protocolSection identificationModule nctId: NCT06275958, orgStudyIdInfo id: 2023-506115-17, secondaryIdInfos id: 2023-506115-17, type: EUDRACT_NUMBER, briefTitle: DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients With Metastatic Colorectal Cancer, acronym: DOSAGE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Leiden University Medical Center, class: OTHER, collaborators name: Dutch Colorectal Cancer Group, collaborators name: Stichting Darmkanker, descriptionModule briefSummary: The goal of this phase III, open-label, non-inferiority randomized controlled clinical trial is compare upfront dose-reduced chemotherapy with the standard dose chemotherapy in older patients ( ≥70 years) with metastasized colorectal cancer, with regard to progression-free survival (PFS). The choice between monotherapy (a fluoropyrimidine) and doublet chemotherapy (a fluoropyrimidine with oxaliplatin) will be made for each individual patient based on expected risk of chemotherapy toxicity (according to the G8 screening). Patients classified as low risk of toxicity will be randomized between doublet chemotherapy in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between monotherapy in either full-dose or upfront dose-reduction.Primary outcome is PFS. Secondary endpoints include grade ≥3 toxicity, QoL, physical functioning, overall survival, number of treatment cycles, dose reductions, hospital admissions, cumulative received dosage and cost-effectiveness., conditionsModule conditions: Older Patients, conditions: Colorectal Cancer, conditions: Metastatic Cancer, conditions: Candidates for Palliative Chemotherapy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A phase III, open-label, non-inferiority, randomized controlled clinical trial comparing dose-reduced chemotherapy versus standard dose chemotherapy in older adults with metastasized colorectal cancer, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 587, type: ESTIMATED, armsInterventionsModule interventions name: Doublet Chemotherapy, Standard Dose (100%), interventions name: Doublet Chemotherapy, Dose-reduced (75%), interventions name: Monotherapy, Standard Dose (100%), interventions name: Monotherapy, Dose-reduced (75%), outcomesModule primaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Quality of Life Questionnaire, secondaryOutcomes measure: Quality of Life Questionnaire, secondaryOutcomes measure: Physical functioning Questionnaire, secondaryOutcomes measure: Physical functioning Questionnaire, secondaryOutcomes measure: Grade 3-5 chemotherapy-related toxicity, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Number of completed treatment cycles, secondaryOutcomes measure: Dose reductions during treatment, secondaryOutcomes measure: Dose delay during treatment, secondaryOutcomes measure: Unplanned hospitalizations, secondaryOutcomes measure: Cumulative received dosage, secondaryOutcomes measure: Cost-effectiveness, eligibilityModule sex: ALL, minimumAge: 70 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jeroen Bosch Ziekenhuis, city: 's-Hertogenbosch, country: Netherlands, geoPoint lat: 51.69917, lon: 5.30417, locations facility: Noordwest Ziekenhuisgroep, city: Alkmaar, country: Netherlands, geoPoint lat: 52.63167, lon: 4.74861, locations facility: Ziekenhuis Amstelland, city: Amstelveen, country: Netherlands, geoPoint lat: 52.30083, lon: 4.86389, locations facility: Amsterdam UMC, city: Amsterdam, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, locations facility: Rijnstate, city: Arnhem, country: Netherlands, geoPoint lat: 51.98, lon: 5.91111, locations facility: Wilhelmina Ziekenhuis, city: Assen, country: Netherlands, geoPoint lat: 52.99667, lon: 6.5625, locations facility: Rode Kruis Ziekenhuis, city: Beverwijk, country: Netherlands, geoPoint lat: 52.48333, lon: 4.65694, locations facility: Haaglanden Medisch Centrum, city: Den Haag, country: Netherlands, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Hagaziekenhuis, city: Den Haag, country: Netherlands, geoPoint lat: 52.07667, lon: 4.29861, locations facility: Slingeland Ziekenhuis, city: Doetinchem, country: Netherlands, geoPoint lat: 51.965, lon: 6.28889, locations facility: Ziekenhuis Gelderse Vallei, city: Ede, country: Netherlands, geoPoint lat: 52.03333, lon: 5.65833, locations facility: Catharina Ziekenhuis, city: Eindhoven, country: Netherlands, geoPoint lat: 51.44083, lon: 5.47778, locations facility: Treant, city: Emmen, country: Netherlands, geoPoint lat: 52.77917, lon: 6.90694, locations facility: Admiraal de Ruyter Ziekenhuis, city: Goes, country: Netherlands, geoPoint lat: 51.50417, lon: 3.88889, locations facility: Beatrixziekenhuis, city: Gorinchem, country: Netherlands, geoPoint lat: 51.83652, lon: 4.97243, locations facility: Groene Hart Ziekenhuis, city: Gouda, country: Netherlands, geoPoint lat: 52.01667, lon: 4.70833, locations facility: Saxenburgh, city: Hardenberg, country: Netherlands, geoPoint lat: 52.57583, lon: 6.61944, locations facility: St. Jansdal Ziekenhuis, city: Harderwijk, country: Netherlands, geoPoint lat: 52.34167, lon: 5.62083, locations facility: Elkerliek Ziekenhuis, city: Helmond, country: Netherlands, geoPoint lat: 51.48167, lon: 5.66111, locations facility: Tergooi MC, city: Hilversum, country: Netherlands, geoPoint lat: 52.22333, lon: 5.17639, locations facility: Medisch Centrum Leeuwarden, city: Leeuwarden, country: Netherlands, geoPoint lat: 53.20139, lon: 5.80859, locations facility: Leiden University Medical Center, city: Leiden, country: Netherlands, geoPoint lat: 52.15833, lon: 4.49306, locations facility: Alrijne Ziekenhuis, city: Leiderdorp, country: Netherlands, geoPoint lat: 52.15833, lon: 4.52917, locations facility: Canisius Wilhelmina Ziekenhuis, city: Nijmegen, country: Netherlands, geoPoint lat: 51.8425, lon: 5.85278, locations facility: Laurentius Ziekenhuis, city: Roermond, country: Netherlands, geoPoint lat: 51.19417, lon: 5.9875, locations facility: Bravis ziekenhuis, city: Roosendaal, country: Netherlands, geoPoint lat: 51.53083, lon: 4.46528, locations facility: Ikazia Ziekenhuis, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Maasstad Ziekenhuis, city: Rotterdam, country: Netherlands, geoPoint lat: 51.9225, lon: 4.47917, locations facility: Ommelander Ziekenhuis, city: Scheemda, country: Netherlands, geoPoint lat: 53.17333, lon: 6.97222, locations facility: ZorgSaam Zorggroep Zeeuws-Vlaanderen, city: Terneuzen, country: Netherlands, geoPoint lat: 51.33583, lon: 3.82778, locations facility: Bernhoven, city: Uden, country: Netherlands, geoPoint lat: 51.66083, lon: 5.61944, locations facility: Diakonessenhuis, city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: St Antonius, city: Utrecht, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: VieCuri Medisch Centrum, city: Venlo, country: Netherlands, geoPoint lat: 51.37, lon: 6.16806, locations facility: Streekziekenhuis Koninging Beatrix, city: Winterswijk, country: Netherlands, geoPoint lat: 51.9725, lon: 6.71944, locations facility: Zaans Medisch Centrum, city: Zaandam, country: Netherlands, geoPoint lat: 52.43854, lon: 4.82643, hasResults: False