RecruitingNCT05655780

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)

Sponsor

Maastricht University Medical Center

Enrollment

104 participants

Start Date

Jan 9, 2023

Study Type

OBSERVATIONAL

Conditions

Colorectal Neoplasms

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at how certain genetic and biological factors — including a patient's tumor type, a gene called UGT1A1, and gut bacteria — affect how well irinotecan-based chemotherapy works in people with advanced or inoperable colorectal cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic or inoperable colorectal cancer - You are about to start irinotecan-based chemotherapy (with or without anti-EGFR therapy) - Your general health is adequate (WHO performance status 0–2) - Your blood counts, liver, and kidney function meet minimum thresholds **You may NOT be eligible if...** - Your tumor has a specific genetic feature called microsatellite instability (MSI) or deficient mismatch repair - You are pregnant or breastfeeding - You have had an ileostomy (a surgical opening in the abdomen for waste) - You are of Asian ethnicity (due to pharmacogenomic differences in the studied genes) - You recently received other systemic cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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