DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer

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.

NCT Number	NCT06275958
Lead Sponsor	Leiden University Medical Center Collaborators: Dutch Colorectal Cancer Group
Conditions	Older Patients, Colorectal Cancer, Metastatic Cancer, Candidates for Palliative Chemotherapy
Enrollment	587 participants
Start Date	2024-07-01
Primary Completion	2028-06 (estimated)
Study Completion	2028-12 (estimated)
Updated on ClinicalTrials.gov	2024-10-16