IRINOTECAN HYDROCHLORIDE for Metastatic colorectal cancer

Inclusion criteria

• {"criterion_text":"-patients aged 18 years or older (no upper age limit)\n-histologically proven metastatic colorectal adenocarcinoma from the primary tumour\n-consent to participate in the study\n-ECOG performance score of 0-2\n-normal haematological and organ functions (serum AST, GOT, GPT -and creatinine- below three times the upper limit of normal, serum bilirubin is below 5xULN, absolute neutrophil count is > 1,5G/L, platelet count >100 G/L; higher AST/GOT/GPT values are allowed in case of liver metastasis upon the investigator’s decision)\n-disease measurable according to RECIST 1.1 and eligibility for delivering CT scan with contrast agents\n-use of high efficacy contraception\n-life expectancy of at least 3 months as judged by the treating physician\n-molecular pathology testing of the tumor specimen (RAS/RAF status + MSI status)"}

Exclusion criteria

• {"criterion_text":"-previous systemic treatment for metastatic disease (adjuvant treatment if completed more than 6 months ago is allowed)\n-MSI-H tumors if there’s no contraindication to immunotherapy\n-known complete DPD deficiency or UGT1A1 polymorphysm (screening is not part of the study due to access difficulties in routine clinical practice)\n-patients who are expected to become eligible for targeted biological therapy after a certain period of time, and who receive FOLFIRI alone only at the beginning of the therapeutic sequence (e.g., in the postoperative period), are not eligible to participate in the study (targeted biological therapy administered in a later line of treatment is permitted within the study)\n-patients eligible for conversion therapy (systemic treatment preceeding surgical resection of CRC metastases)\n-patients requiring rapid regression (preferentially treated with FOLFOX)\n-oligometastatic disease where the tumor board indicates ablative local treatment of metastases\n-severe organ dysfunction; severe internal or chronic infectious disease excluding oncology treatment; acute, severely symptomatic infectious disease within 2 weeks prior to treatment\n-other treatment for oncological purposes within 4 weeks prior to treatment (palliative, decompressive or analgetic radiotherapy is allowed)\n-history of hypersensitivity to study agents"}

Primary endpoints

• {"endpoint_text":"-Progression-Free Survival (PFS) assessed by the investigators","definition_or_measurement_approach":"Assessed by the investigators based on the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v.1.1)."}

Secondary endpoints

• {"endpoint_text":"-Overall Survival (OS) data in both treatment arms","definition_or_measurement_approach":"Overall survival measured as time from randomisation/enrollment to death from any cause (definition as stated: Overall Survival (OS))."}
• {"endpoint_text":"-Time on treatment (ToT) periods in both treatment arms","definition_or_measurement_approach":"Time on treatment measured as duration participants remain on assigned treatment (Time on Treatment (ToT))."}
• {"endpoint_text":"-AE, SAE events by CTCAE v.5.","definition_or_measurement_approach":"Adverse events and serious adverse events graded and reported using CTCAE version 5."}

Hungary

Earliest CTIS Part Ii Submission Date

25-06-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

23

Number Of Sites

1

Number Of Participants

56

Primary sponsor

Full Name

University Of Pecs

Organisation Type

Educational Institution

Country Of Registered Address

Hungary