NCT06275958 DOSAGE Study: Upfront Dose-Reduced Chemotherapy in Older Patients with Metastatic Colorectal Cancer
| NCT ID | NCT06275958 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Leiden University Medical Center |
| Condition | Older Patients |
| Study Type | INTERVENTIONAL |
| Enrollment | 587 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 587 participants in total. It began in 2024-07-01 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Johanneke Portielje, Professor
PRINCIPAL INVESTIGATOR
Leiden University Medical Center
Frequently Asked Questions
Who can join the NCT06275958 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Older Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06275958 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 587 participants.
Is NCT06275958 currently recruiting?
Yes, NCT06275958 is actively recruiting participants. Contact the research team at DOSAGE@lumc.nl for enrollment information.
Where is the NCT06275958 trial being conducted?
This trial is being conducted at 's-Hertogenbosch, Netherlands, Alkmaar, Netherlands, Amstelveen, Netherlands, Amsterdam, Netherlands and 11 additional locations.
Who is sponsoring the NCT06275958 clinical trial?
NCT06275958 is sponsored by Leiden University Medical Center. The principal investigator is Johanneke Portielje, Professor at Leiden University Medical Center. The trial plans to enroll 587 participants.