OncoMatch/Clinical Trials/NCT06275958
DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
Is NCT06275958 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Doublet Chemotherapy, Standard Dose (100%) and Doublet Chemotherapy, Dose-reduced (75%) for older patients.
Treatment: Doublet Chemotherapy, Standard Dose (100%) · Doublet Chemotherapy, Dose-reduced (75%) · Monotherapy, Standard Dose (100%) · Monotherapy, Dose-reduced (75%) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Tumor Agnostic
Biomarker criteria
Excluded: DPYD complete or incomplete deficiency
Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency
Excluded: MSH2 MSI-high
Patients with Microsatellite instable (MSI)-high colorectal cancer
Disease stage
Metastatic disease required
distant metastases without localized treatment options
Prior therapy
Cannot have received: palliative chemotherapy
Patients who received prior palliative chemotherapy
Cannot have received: adjuvant chemotherapy
Exception: chemotherapy before one year prior to inclusion is allowed
Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1.5 x 10^9 mmol/L, Hemoglobin (Hb) > 6.0 mmol/L, Platelets >100 x 10^9 / L
Kidney function
Severe kidney failure (defined as GFR ≤30ml/min) [excluded]
Liver function
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
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 10^9 / 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. Patients with severe kidney failure (defined as GFR ≤30ml/min) [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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