Status:
UNKNOWN
Intraperitoneal Irinotecan With Concomitant FOLFOX and Bevacizumab
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Conditions:
Colorectal Cancer
Peritoneal Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The rationale of the current study is that the addition of intraperitoneal irinotecan (75 mg) to palliative systemic therapy is feasible and safe, and might result in an increased overall and progress...
Eligibility Criteria
Inclusion
- Histologically confirmed colorectal cancer;
- Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI \>20, extensive small bowel involvement, unresectable disease 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
- Presence of extensive systemic metastases that are deemed to be the dominant factor determining prognosis in terms of life expectancy and performance status \[e.g. no imminent threat of impaired organ functioning due to the presence of systemic metastases\]);
- Prior cytoreductive surgery;
- Prior palliative systemic therapy for colorectal cancer;
- Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months;
- 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, serious concomitant disease, severe allergy), as determined by the medical oncologist;
- Inadequate organ functions, defined as an haemoglobin of \<5 mmol/L, an absolute neutrophil 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 liver transaminases of \>5 x ULN.
Key Trial Info
Start Date :
December 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06003998
Start Date
December 27 2022
End Date
January 1 2025
Last Update
August 22 2023
Active Locations (2)
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1
Catharina Hospital
Eindhoven, Netherlands
2
Erasmus Medical Centre
Rotterdam, Netherlands