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Upfront dose-reduced chemotherapy for older patients with metastatic colorectal cancer

DOSAGE Study: a Multicenter Randomized Phase III Trial of DOSe-reduced Chemotherapy for Advanced Colorectal Cancer in Older Patients

Phase 3 Interventional Leiden University Medical Center · NCT06275958

This study is testing whether giving lower doses of chemotherapy can help older patients with advanced colorectal cancer live longer and feel better compared to the standard full doses.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment587 (estimated)
Ages70 Years and up
SexAll
SponsorLeiden University Medical Center Academic / other
Drugs / interventionschemotherapy, bevacizumab
Locations36 sites ('s-Hertogenbosch and 35 other locations)
Trial IDNCT06275958 on ClinicalTrials.gov

What this trial studies

This phase III, open-label, non-inferiority randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard dose chemotherapy in older patients (≥70 years) diagnosed with metastatic colorectal cancer. Patients will be screened using the G8 questionnaire to assess their risk of chemotherapy toxicity, and based on this, they will be randomized to receive either monotherapy or doublet chemotherapy at full or reduced doses. The primary outcome is progression-free survival (PFS), while secondary outcomes include toxicity levels, quality of life, and overall survival. The study seeks to establish a safer treatment approach for older adults who are often at higher risk for chemotherapy-related complications.

Who should consider this trial

Good fit: Ideal candidates are patients aged 70 years or older with metastatic colorectal cancer who are eligible for first-line palliative chemotherapy.

Not a fit: Patients who have received prior palliative chemotherapy or those scheduled for local treatment of metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved quality of life and reduced toxicity for older patients undergoing chemotherapy for metastatic colorectal cancer.

How similar studies have performed: Other studies have explored dose-reduced chemotherapy in older populations, but this specific approach is novel in the context of metastatic colorectal cancer.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

's-Hertogenbosch and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Older PatientsColorectal CancerMetastatic CancerCandidates for Palliative ChemotherapyDose-reduced ChemotherapyUpfront ReductionPalliative ChemotherapyNon-inferiority
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.