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

Recruiting now

Conditions studied: Colorectal Neoplasms

In brief

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.

Key facts

Study ID

NCT05655780

Run by

Maastricht University Medical Center

People needed

104

Starts

2023-01-09

Expected to finish

2028-12-01

Last updated by the study team

2025-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Microsatellite instability (MSI) or deficient MMR proteins
• Pregnant or nursing
• Presence of ileostomy
• Asian ethnicity
• 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
• 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.

Where it is running

• Maastricht UMC+ — Maastricht, Limburg, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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