COSENSE-1: A Feasibility Study for Using a Functional Precision Medicine Platform to Select Oxaliplatin-based Versus Irinotecan-based Chemotherapy Regimens for Patients With Metastatic Colorectal Cancer
COSENSE-1 is an unblinded, phase II, single-armed, single center feasibility study for using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens, for male and female participants aged 18 and older, with microsatellite stable (MSS)/proficient mismatch repair (pMMR) metastatic colorectal cancer (mCRC), that is incurable or not resectable with curative intent.
‣ General conditions:
• Age 18 or older
• ECOG performance status 0 or 1
• Obtained informed consent
• Acceptable organ function (defined in publicly available protocol)
• Women of child-bearing potential and men must agree to use highly effective contraception (defined in publicly available protocol)
• Disease and treatment specific conditions:
• Histologically confirmed pMMR/MSS adenocarcinoma originating from the colon or rectum
• Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)
• Patient has metastatic or primary lesion available for biopsy
• Patient has measurable or evaluable disease per RECIST (version 1.1)
⁃ 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 (https://www.helsedirektoratet.no/retningslinjer/kreft-i-tykktarm-og-endetarm-handlingsprogram)
⁃ Patient is eligible for full (100%) chemotherapy doses at first treatment cycle
⁃ Treatment with chemotherapy can be scheduled within 28 days from referral