NCT05655780Recruiting
The Role of the Tumor Molecular Profile (CMS), UGT1A1 Genotype and Beta-glucuronidase Activity of the Intestinal Microbiota for Treatment Efficiency, Toxicity, Survival and Quality of Life in Patients With Metastatic or Unresectable Colorectal Cancer During Irinotecan-based Systemic Treatment
Optimal Survival and Quality of Life in Patients With Metastatic Colorectal Cancer With Irinotecan Dosing Based on UGT1A1 Genotype and Gut Microbiota Enzyme Activity Including a Dietary Intervention (OPTIMA)
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Irinotecan-based systemic therapy is a treatment option for metastatic or unresectable colorectal cancer. However, this therapy has two major disadvantages, namely, an unpredictable response to the treatment and severe side effects, for instance diarrhea or a low white blood cell count (neutropenia). Therefore, the OPTIMA study was developed to find out if biomarkers, such as the molecular profile of the tumor, the UGT1A1 genotype and activity of the bacterial enzyme β-glucuronidase, can predict response and side effects during irinotecan treatment. By looking at these biomarkers, treatments could be more personalized, resulting into enhanced therapy efficiency, increased optimal survival and a better quality of life.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 104 (estimated)
- First submitted
- 8 Dec 2022
- Start date
- 9 Jan 2023
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT05655780
What you commit to
- Study type: Observational
- Planned participants: 104
- From 9 Jan 2023 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other systemic treatment is less than one month before the start of the irinotecan-based treatment
- Therapeutic antibiotic use is less than three months before the start of the irinotecan-based treatment
- Abdominal radiotherapy is less than two weeks before the start of the irinotecan-based treatment
Other
- Microsatellite instability (MSI) or deficient MMR proteins
- Pregnant or nursing
- Presence of ileostomy
- Asian ethnicity
- Physically or mentally incapable or incompetent
- More than 25% irinotecan dose reduction at the start of treatment (dose reductions during treatment are allowed), with exception of dose reduction due to UGT1A1 mutation.
Who the study is looking for
- Adult patient: 18 years of age or older
- Patients diagnosed with metastatic or unresectable CRC, who will be treated with irinotecan-based systemic therapy with or without anti-eGFR treatment.
- WHO performance status 0-2
- Minimal acceptable safety laboratory values defined as:
- ANC of ≥ 1.5 x 109 /L
- Platelet count of ≥ 100 x 109 /L
- Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 2.5 x ULN; in case of liver metastases ALAT and ASAT ≤ 5 x ULN.
- Renal function (eGFR) ≥ 50 ml/min or OR creatinine ≤ 1.5 x ULN
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Maastricht UMC Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.