Exploring biomarkers to improve treatment for metastatic colorectal cancer
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)
This study is testing if certain biological markers can help doctors tailor treatment for people with advanced colorectal cancer to improve their response to medication and reduce side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05655780 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of tumor molecular profiles, UGT1A1 genotype, and intestinal microbiota enzyme activity in predicting treatment response and side effects for patients with metastatic or unresectable colorectal cancer undergoing irinotecan-based therapy. By identifying specific biomarkers, the study aims to personalize treatment, potentially enhancing efficacy and minimizing toxicity. The research focuses on understanding how these factors influence patient outcomes, including survival and quality of life, during systemic treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with metastatic or unresectable colorectal cancer who are set to receive irinotecan-based systemic therapy.
Not a fit: Patients with microsatellite instability or deficient MMR proteins, as well as those with certain recent treatments or conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with metastatic colorectal cancer.
How similar studies have performed: Previous studies have shown promising results in using biomarkers to predict treatment outcomes in similar contexts, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≥ 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 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.
Where this trial is running
Maastricht, Limburg
- Maastricht UMC+ — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marjolein Smidt, Prof. dr. — Maastricht University Medical Center
- Study coordinator: Janine Ziemons, M.Sc.
- Email: j.ziemons@maastrichtuniversity.nl
- Phone: +31 (0)433881558
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.