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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Catharina Ziekenhuis
  Eindhoven, Netherlands Recruiting
• Groene Hart Ziekenhuis
  Gouda, Netherlands Recruiting
• Elkerliek Ziekenhuis
  Helmond, Netherlands Recruiting
• Tergooi MC
  Hilversum, Netherlands Recruiting
• Leiden University Medical Center
  Leiden, Netherlands Recruiting
• Bravis ziekenhuis
  Roosendaal, Netherlands Recruiting

Study contacts

• Principal investigator: Johanneke Portielje, Professor — Leiden University Medical Center
• Study coordinator: Joosje Baltussen
• Email: DOSAGE@lumc.nl
• Phone: 071 - 526 35 23

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.