Last updated: August 15, 2023
Sponsor: Catharina Ziekenhuis Eindhoven
Overall Status: Active - Recruiting
Phase
2
Condition
Colorectal Cancer
Cancer
Rectal Cancer
Treatment
Irinotecan
FOLFOX regimen
Bevacizumab
Clinical Study ID
NCT06003998
NL81672.100.22
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed colorectal cancer;
- Radiologically and clinically or pathologically confirmed unresectable colorectalperitoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectabledisease due to anatomical location);
- WHO performance score of 0-1 with a life expectancy of >3 months;
- Aged 18 years or older;
- Written informed consent;
Exclusion
Exclusion Criteria:
- Presence of extensive systemic metastases that are deemed to be the dominant factordetermining prognosis in terms of life expectancy and performance status [e.g. noimminent threat of impaired organ functioning due to the presence of systemicmetastases]);
- Prior cytoreductive surgery;
- Prior palliative systemic therapy for colorectal cancer;
- Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6months;
- Homozygous UGT1A1*28 genotype;
- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency
- Microsatellite instable (MSI) primary tumor
- Any contra-indication for the planned chemotherapy (e.g. active infection, seriousconcomitant disease, severe allergy), as determined by the medical oncologist;
- Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absoluteneutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L, serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin > 2x ULN and livertransaminases of >5 x ULN.
Study Design
Total Participants: 85
Treatment Group(s): 3
Primary Treatment: Irinotecan
Phase: 2
Study Start date:
December 27, 2022
Estimated Completion Date:
January 01, 2025
Connect with a study center
Catharina Hospital
Eindhoven,
NetherlandsActive - Recruiting
Erasmus Medical Centre
Rotterdam,
NetherlandsActive - Recruiting
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