Irinotecan hydrochloride trihydrate for Metastatic colorectal cancer (MSS/pMMR)

Inclusion criteria

• {"criterion_text":"- Age 18 or older\n- Obtained written informed consent\n- ECOG performance status 0 or 1\n- Documented pMMR/MSS colorectal cancer adenocarcinoma by histology or cytology, or, when biopsy is contraindicated/not feasible within required timeframes, unequivocal clinical–radiological-biomedical evidence of colorectal cancer confirmed by MDT review\n- The oxaliplatin-based regimen FOLFOX (+/- antibody) versus the irinotecan-based regimen FOLFIRI (+/- antibody), are evaluated by an experienced physician, independent of inclusion in the trial, to be equally recommended for the participant as standard of care first-line therapy in the treatment of mCRC, following the Norwegian national guideline on the treatment of colorectal cancer\n- Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)\n- Patient has measurable or evaluable disease per RECIST (version 1.1)"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus\n- Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion\n- Inability to understand study procedures and comply with them, or disorder that compromises the patient’s ability to provide informed consent and/or comply with study procedures\n- Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency\n- Patient has metastatic MMR deficient/MSI adenocarcinoma\n- ECOG performance status 2 or worse\n- Patient is not equally eligible for FOLFOX (+/- antibody) and FOLFIRI (+/- antibody) chemotherapy regimens, according to the Norwegian national guideline on the treatment of colorectal cancer"}

Primary endpoints

• {"endpoint_text":"- The rate of generating valid tumouroid response reports (valid is defined as a fper patienold-change growth in untreated controls of > 1, registered on day 5, 6, 7 or 8 and normalised with resepect to day 0 or 1): a) t included in the trial and b) per patient with obtained tumour samples, and 2) the time from referral to start of allocated treatment.","definition_or_measurement_approach":"Valid tumouroid response reports defined in-text as a relative change in growth in untreated controls of > 1, registered on day 5, 6, 7 or 8 and normalised with respect to day 0 or 1; reported a) per patient included in the trial and b) per patient with obtained tumour samples. Also includes measurement of time from referral to start of allocated treatment."}
• {"endpoint_text":"- What is the time from referral to start of allocated treatment","definition_or_measurement_approach":"Measured as the time interval from referral to the start date of the allocated treatment."}

Secondary endpoints

• {"endpoint_text":"- Response Rates (RR) including ORR, according to RECIST v1.1. criteria","definition_or_measurement_approach":"Objective response rates assessed by RECIST v1.1 (includes ORR)."}
• {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Time from treatment start (or defined baseline) to death from any cause."}
• {"endpoint_text":"- Progression Free Survival (PFS), defined as the time from starting first-line treatment to the time of documentation of PD according to RECIST on active therapy, determined failure of treatment strategy or death","definition_or_measurement_approach":"PFS defined explicitly as time from starting first-line treatment to documentation of progressive disease per RECIST while on active therapy, determination of treatment strategy failure, or death."}
• {"endpoint_text":"- Progression Free Survival Rate at 6 months","definition_or_measurement_approach":"Proportion of patients alive and without documented progression at 6 months."}
• {"endpoint_text":"- Disease Control Rate (DCR) assessed with RECIST v1.1","definition_or_measurement_approach":"DCR assessed per RECIST v1.1 criteria (typically CR+PR+SD)."}
• {"endpoint_text":"- Clinical Benefit Rate (CBR), defined as the percentage of patients who had a complete response, partial response, or had stable disease for 6 months or more","definition_or_measurement_approach":"CBR defined as percentage of patients with CR, PR, or stable disease lasting ≥6 months."}
• {"endpoint_text":"- Toxicity graded with the CTCAE v.5.0: incidence of grade 3-5 adverse events","definition_or_measurement_approach":"Incidence of grade 3–5 adverse events graded according to CTCAE v5.0."}

Norway

Earliest CTIS Part Ii Submission Date

13-12-2024

Latest Decision Or Authorization Date

30-01-2026

Processing Time Days

413

Number Of Sites

1

Number Of Participants

148

Primary sponsor

Full Name

St. Olavs Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway