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

RecruitingPhase 3Ages 70 Years - anyAllLeiden University Medical Center
NCT06275958 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 70 years or older with colorectal cancer and distant metastases without localized treatment options. * Patients who are candidates for first-line palliative chemotherapy as judged by their treating oncologist * Being able to understand the Dutch language * 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. Exclusion Criteria: * Patients who received prior palliative chemotherapy * Patients in whom local treatment of metastases is scheduled (i.e. liver surgery or stereotactic radiotherapy) * Candidates for triple chemotherapy * Patients who received prior adjuvant chemotherapy in the one year before inclusion in the study (chemotherapy before that time is allowed) * Patients with complete or incomplete dihydropyrimidine dehydrogenase (DPD) deficiency * Patients with Microsatellite instable (MSI)-high colorectal cancer * Patients with HIV or active hepatitis * Patients with severe kidney failure (defined as GFR ≤30ml/min) * Patients with severe cognitive deficits making informed consent not possible
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What it tests

  • Doublet Chemotherapy, Standard Dose (100%)
  • Doublet Chemotherapy, Dose-reduced (75%)
  • Monotherapy, Standard Dose (100%)
  • Monotherapy, Dose-reduced (75%)
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Where

36 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuis Amstelland
Amstelveen, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Wilhelmina Ziekenhuis
Assen, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands

…and 28 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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