Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT06275958
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
70 Years
Study:
NCT06275958
Study Brief:
Protocol Section:
NCT06275958