Irinotecan hydrochloride trihydrate for Unresectable peritoneal metastases of colorectal cancer

Inclusion criteria

• {"criterion_text":"- Histologically confirmed colorectal cancer;\n- Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectable disease due to anatomical location);\n- WHO performance score of 0-1 with a life expectancy of >3 months;\n- Aged 18 years or older;\n- Written informed consent."}

Exclusion criteria

• {"criterion_text":"- 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]);\n- Prior cytoreductive surgery;\n- Prior palliative systemic therapy for colorectal cancer;\n- Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months;\n- Homozygous UGT1A1*28 genotype;\n- Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency;\n- Microsatellite instable (MSI) primary tumor;\n- 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."}

Primary endpoints

• {"endpoint_text":"- To determine the anti-tumor activity in patients treated with intraperitoneal irinotecan (75 mg) and concomitant palliative systemic therapy, in terms of overall survival (calculated from (a) the interval from diagnosis of peritoneal metastases until death or last follow-up; (b) the interval from the first day of the first cycle until death or last follow-up).","definition_or_measurement_approach":"Overall survival, calculated from (a) interval from diagnosis of peritoneal metastases until death or last follow-up; and (b) interval from the first day of the first cycle until death or last follow-up."}

Netherlands

Earliest CTIS Part Ii Submission Date

02-09-2024

Latest Decision Or Authorization Date

03-09-2024

Processing Time Days

1

Number Of Sites

3

Number Of Participants

85

Primary sponsor

Full Name

Catharina Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands