AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

Recruitingn/aAges 18 Years - anyAllMaastricht University Medical Center
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 ฮฒ-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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ฅ 1.5 x 109 /L * Platelet count of โ‰ฅ 100 x 109 /L * Hepatic function as defined by serum bilirubin โ‰ค 1.5 x ULN, ALAT and ASAT โ‰ค 2.5 x ULN; in case of liver metastases ALAT and ASAT โ‰ค 5 x ULN. * Renal function (eGFR) โ‰ฅ 50 ml/min or OR creatinine โ‰ค 1.5 x ULN * Written informed consent Exclusion Criteria: * 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.
๐Ÿ’Š

What it tests

  • Not listed
๐Ÿ“

Where

1 site
Maastricht UMC+
Maastricht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy