Colorectal Cancer with metastasis in the peritoneum Peritoneal carcinomatosis of colorectal origin
Conditions
Interventions
The addition of intraperitoneal irinotecan (75 mg) to modified FOLFOX4
(mFOLFOX4) + bevacizumab
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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 criteria
Exclusion criteria: - 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 1.5 x ULN, creatinine clearance of 2x ULN and liver transaminases of >5 x ULN;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the anti-tumor activity in patients treated with intraperitoneal irinotecan (75 mg) and concomitant mFOLFOX4, defined as (1) progression-free survival (calculated from the interval from the start of trial treatment until first evidence of intraperitoneal and/or systemic disease progression or last follow-up); (2) 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| The toxicity profile, patient reported outcomes, costs, tumor response during trial treatment, and the systemic and intraperitoneal pharmacokinetics of irinotecan and SN-38. | — |
Countries
Netherlands
Outcome results
None listed