Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06275958
Status:
RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', '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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 587}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-14', 'studyFirstSubmitDate': '2024-02-06', 'studyFirstSubmitQcDate': '2024-02-16', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-Free Survival', 'timeFrame': 'Time from randomization until either radiological or clinical progression or death, whichever occurs first, assessed up to at least one year.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Questionnaire', 'timeFrame': 'At 1, 3, 6 and 12 months after randomization', 'description': 'Measured by EQ-5D questionnaire'}, {'measure': 'Quality of Life Questionnaire', 'timeFrame': 'At 1, 3, 6 and 12 months after randomization', 'description': 'Measured by EORTC Core QLQ-C30 questionnaire'}, {'measure': 'Physical functioning Questionnaire', 'timeFrame': 'At 1, 3, 6 and 12 months after randomization', 'description': 'Measured by Lawton-Instrumental Activities of Daily Living (IADL) questionnaire'}, {'measure': 'Physical functioning Questionnaire', 'timeFrame': 'At 1, 3, 6 and 12 months after randomization', 'description': 'Measured by Katz-Activities of Daily Living (ADL) questionnaire'}, {'measure': 'Grade 3-5 chemotherapy-related toxicity', 'timeFrame': 'Through study duration, an average of 8 months', 'description': 'According to the CTCAE V5'}, {'measure': 'Overall Survival', 'timeFrame': 'Time between randomization until death, assessed up to at least one year.'}, {'measure': 'Number of completed treatment cycles', 'timeFrame': 'Through study duration, an average of 8 months'}, {'measure': 'Dose reductions during treatment', 'timeFrame': 'Through study duration, an average of 8 months', 'description': 'Defined as ≥25% reduction of the initial dosage'}, {'measure': 'Dose delay during treatment', 'timeFrame': 'Through study duration, an average of 8 months'}, {'measure': 'Unplanned hospitalizations', 'timeFrame': 'The first year after treatment initiation'}, {'measure': 'Cumulative received dosage', 'timeFrame': 'Through study duration, an average of 8 months', 'description': 'Adjusted for BSA'}, {'measure': 'Cost-effectiveness', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dose-reduced Chemotherapy', 'Upfront Reduction', 'Palliative Chemotherapy', 'Non-inferiority'], 'conditions': ['Older Patients', 'Colorectal Cancer', 'Metastatic Cancer', 'Candidates for Palliative Chemotherapy']}, 'referencesModule': {'references': [{'pmid': '39142680', 'type': 'DERIVED', 'citation': 'Baltussen JC, van den Bos F, Slingerland M, Binda TRR, Liefers GJ, van den Hout WB, Fiocco M, Verschoor AJ, Cloos-van Balen M, Holterhues C, Houtsma D, Jochems A, Spierings LEAMM, van Bodegom-Vos L, Mooijaart SP, Gelderblom H, Speetjens FM, de Glas NA, Portielje JEA. DOSAGE study: protocol for a phase III non-inferiority randomised trial investigating dose-reduced chemotherapy for advanced colorectal cancer in older patients. BMJ Open. 2024 Aug 13;14(8):e089882. doi: 10.1136/bmjopen-2024-089882.'}], 'seeAlsoLinks': [{'url': 'https://dccg.nl/trial/dosage', 'label': 'DCCG Website'}]}, '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.\n\nPrimary 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.', 'detailedDescription': 'Treating older adults with chemotherapy remains a challenge, as they are strongly underrepresented in clinical trials and no robust guidelines for treating older patients exist. Moreover, older adults are at increased risk of chemotherapy-related toxicity, resulting in decreased quality of life (QoL), increased hospital admissions and high health care costs. Therefore, the aim of the DOSAGE study is to demonstrate that upfront dose-reduced chemotherapy in patients with metastasized colorectal cancer is non-inferior to full-dose treatment with regard to progression-free survival (PFS). Treatment plans (monotherapy or doublet chemotherapy) will be based on expected risk of treatment toxicity for the individual patient (according to the Geriatric 8 (G8) questionnaire). The investigators expect that this treatment strategy will lead to less grade ≥3 toxicity, less early treatment continuation and hospitalizations and a better QoL and physical functioning.\n\nThe DOSAGE study is a phase III, open-label, non-inferiority, randomized controlled clinical trial in patients aged ≥70 years with metastasized colorectal cancer eligible for palliative chemotherapy. All participating patients will undergo geriatric screening by the G8 questionnaire and will be classified as "low risk of toxicity" (G8-score of 15 or higher) or "high risk of toxicity" (G8-score of 14 or lower or judged as "high toxicity risk" by their treating oncologist). Patients classified as low risk will be randomized between a fluoropyrimidine and oxaliplatin in either full-dose, or with an upfront dose-reduction of 25%. Patients classified as high risk will be randomized between fluoropyrimidine monotherapy in either full-dose or upfront dose-reduction. Addition of targeted treatment (bevacizumab or epidermal growth factor receptor (EGFR) inhibition) is allowed. Patients with a moderate renal impairment (GFR 30- 50 mL/min) will be treated with 25% reduced starting dose of capecitabine when randomized for full dose treatment and treated with 40% reduced starting dose when randomized for upfront dose reduction.\n\nPrimary 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. Given a non-inferiority margin of 8 weeks, 587 patients will be included (293/292 patients per arm).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options.\n* Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist\n* Being able to understand the Dutch language\n* Adequate bone marrow and organ function: Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9 mmol/L, Hemoglobin (Hb) \\> 6.0 mmol/L, Platelets \\>100 x 109 / L, Serum bilirubin ≤ 2 x upper limit of normal (ULN), serum transaminases ≤ 3 x ULN without presence of liver metastases or ≤ 5x ULN with presence of liver metastases.\n\nExclusion Criteria:\n\n* Patients who received prior palliative chemotherapy\n* Patients in whom local treatment of metastases is scheduled (i.e. liver surgery or stereotactic radiotherapy)\n* Candidates for triple chemotherapy\n* Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed)\n* Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency\n* Patients with Microsatellite instable (MSI)-high colorectal cancer\n* Patients with HIV or active hepatitis\n* Patients with severe kidney failure (defined as GFR ≤30ml/min)\n* Patients with severe cognitive deficits making informed consent not possible'}, 'identificationModule': {'nctId': 'NCT06275958', 'acronym': 'DOSAGE', 'briefTitle': 'DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Leiden University Medical Center'}, 'officialTitle': 'DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients', 'orgStudyIdInfo': {'id': '2023-506115-17'}, 'secondaryIdInfos': [{'id': '2023-506115-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Doublet therapy, full dose (low toxicity risk based on G8)', 'description': 'Low risk of toxicity: G8-score of 15 or higher', 'interventionNames': ['Drug: Doublet Chemotherapy, Standard Dose (100%)']}, {'type': 'EXPERIMENTAL', 'label': 'Doublet therapy, dose-reduced (low toxicity risk based on G8)', 'description': 'Low risk of toxicity: G8-score of 15 or higher', 'interventionNames': ['Drug: Doublet Chemotherapy, Dose-reduced (75%)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoropyrimidine monotherapy, full dose (high toxicity risk based on G8)', 'description': 'High risk of toxicity: G8-score of 14 or lower or judged as "high toxicity risk" by their treating oncologist', 'interventionNames': ['Drug: Monotherapy, Standard Dose (100%)']}, {'type': 'EXPERIMENTAL', 'label': 'Fluoropyrimidine monotherapy, dose-reduced (high toxicity risk based on G8)', 'description': 'High risk of toxicity: G8-score of 14 or lower or judged as "high toxicity risk" by their treating oncologist', 'interventionNames': ['Drug: Monotherapy, Dose-reduced (75%)']}], 'interventions': [{'name': 'Doublet Chemotherapy, Standard Dose (100%)', 'type': 'DRUG', 'description': 'Capecitabine 1000mg / m2 oral at day 1-14 (every 3 weeks) Oxaliplatin 130mg/m2 at day 1 (every 3 weeks) OR 5-FU 400mg/m2 IV bolus at day 1 followed by 2400mg/m2 in 46 hours (every 2 weeks) Leucovorin 400mg/m2 day 1 (every 2 weeks) Oxaliplatin 85mg/m2 day 1 (every 2 weeks)', 'armGroupLabels': ['Doublet therapy, full dose (low toxicity risk based on G8)']}, {'name': 'Doublet Chemotherapy, Dose-reduced (75%)', 'type': 'DRUG', 'description': '75% of: Capecitabine 1000mg / m2 oral at day 1-14 (every 3 weeks) Oxaliplatin 130mg/m2 at day 1 (every 3 weeks) OR 5-FU 400mg/m2 IV bolus at day 1 followed by 2400mg/m2 in 46 hours (every 2 weeks) Leucovorin 400mg/m2 day 1 (every 2 weeks) Oxaliplatin 85mg/m2 day 1 (every 2 weeks)', 'armGroupLabels': ['Doublet therapy, dose-reduced (low toxicity risk based on G8)']}, {'name': 'Monotherapy, Standard Dose (100%)', 'type': 'DRUG', 'description': '\\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)', 'armGroupLabels': ['Fluoropyrimidine monotherapy, full dose (high toxicity risk based on G8)']}, {'name': 'Monotherapy, Dose-reduced (75%)', 'type': 'DRUG', 'description': '75% of:\n\n\\- Capecitabine 1000mg/m2 oral at day 1-14 (every 3 weeks)', 'armGroupLabels': ['Fluoropyrimidine monotherapy, dose-reduced (high toxicity risk based on G8)']}]}, 'contactsLocationsModule': {'locations': [{'city': "'s-Hertogenbosch", 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'city': 'Alkmaar', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Noordwest Ziekenhuisgroep', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'city': 'Amstelveen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Ziekenhuis Amstelland', 'geoPoint': {'lat': 52.30083, 'lon': 4.86389}}, {'city': 'Amsterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Arnhem', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Rijnstate', 'geoPoint': {'lat': 51.98, 'lon': 5.91111}}, {'city': 'Assen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 52.99667, 'lon': 6.5625}}, {'city': 'Beverwijk', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Rode Kruis Ziekenhuis', 'geoPoint': {'lat': 52.48333, 'lon': 4.65694}}, {'city': 'Doetinchem', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Slingeland Ziekenhuis', 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{'city': 'Hardenberg', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Saxenburgh', 'geoPoint': {'lat': 52.57583, 'lon': 6.61944}}, {'city': 'Harderwijk', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'St. Jansdal Ziekenhuis', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'city': 'Helmond', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Elkerliek Ziekenhuis', 'geoPoint': {'lat': 51.48167, 'lon': 5.66111}}, {'city': 'Hilversum', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Tergooi MC', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'city': 'Leeuwarden', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Leiden', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Leiderdorp', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Alrijne Ziekenhuis', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'city': 'Nijmegen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Canisius Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Roermond', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Laurentius Ziekenhuis', 'geoPoint': {'lat': 51.19417, 'lon': 5.9875}}, {'city': 'Roosendaal', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Bravis ziekenhuis', 'geoPoint': {'lat': 51.53083, 'lon': 4.46528}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Ikazia Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Rotterdam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Maasstad Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Scheemda', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Ommelander Ziekenhuis', 'geoPoint': {'lat': 53.17333, 'lon': 6.97222}}, {'city': 'Terneuzen', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'ZorgSaam Zorggroep Zeeuws-Vlaanderen', 'geoPoint': {'lat': 51.33583, 'lon': 3.82778}}, {'city': 'The Hague', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Haaglanden Medisch Centrum', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'The Hague', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Hagaziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Uden', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Bernhoven', 'geoPoint': {'lat': 51.66083, 'lon': 5.61944}}, {'city': 'Utrecht', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Diakonessenhuis', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Utrecht', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'St Antonius', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Venlo', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'VieCuri Medisch Centrum', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'city': 'Winterswijk', 'status': 'RECRUITING', 'country': 'Netherlands', 'facility': 'Streekziekenhuis Koninging Beatrix', 'geoPoint': {'lat': 51.9725, 'lon': 6.71944}}, {'city': 'Zaandam', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'facility': 'Zaans Medisch Centrum', 'geoPoint': {'lat': 52.43854, 'lon': 4.82643}}], 'centralContacts': [{'name': 'Joosje Baltussen', 'role': 'CONTACT', 'email': 'DOSAGE@lumc.nl', 'phone': '071 - 526 35 23'}, {'name': 'Data Management: Clinical Research Center LUMC', 'role': 'CONTACT', 'email': 'ClinicalResearchCenter@lumc.nl'}], 'overallOfficials': [{'name': 'Johanneke Portielje, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Center'}, {'name': 'Joosje Baltussen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Leiden University Medical Center'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'The datasets generated and/or analysed during the current study are not publicly available due to patient privacy but are available from the corresponding author on reasonable request', 'ipdSharing': 'YES', 'description': "Which parts of your data(sets) will you select for publication?\n\nThe datasets generated during and/or analysed during the study will not be publicly available due to participant privacy but will be available from the corresponding author on reasonable request\n\nAre there any restrictions placed on sharing/reuse of some/all of your data due to one or more of the following options? Signed informed consent Research agreement\n\nWill you publish your data open access or with restricted access? Restricted access\n\nPublishing your data (partly) with 'restricted access': what is the reason for this? Data contains privacy-sensitive information Contractual obligations Reuse by third-party through DSA.\n\nWhere will you publish your (meta)data? I will not publish (meta)data outside the LUMC"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Leiden University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dutch Colorectal Cancer Group', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Medical Oncology', 'investigatorFullName': 'Johanna E A Portielje, MD PhD', 'investigatorAffiliation': 'Leiden University Medical Center'}}}}