Actively Recruiting
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
Led by Maastricht University Medical Center · Updated on 2025-05-18
104
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
M
Maastricht University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Adult patient: 18 years of age or older
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Patients diagnosed with metastatic or unresectable CRC, who will be treated with irinotecan-based systemic therapy with or without anti-eGFR treatment.
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WHO performance status 0-2
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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
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Written informed consent
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Maastricht UMC+
Maastricht, Limburg, Netherlands, 6229 HX
Actively Recruiting
Research Team
J
Janine Ziemons, M.Sc.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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