Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Olavs Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age 18 or older

ECOG performance status 0 or 1

Obtained informed consent

Acceptable organ function (defined in publicly available protocol)

Disqualifiers

Patient has metastatic MMR deficient/MSI adenocarcinoma

Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle

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

ECOG performance status 2 or worse

Trial design

Treatments tested in this trial

  • FOLFOX or FOLFIRI

Treatment groups

148 Participants
are divided into 1 treatment group

Sponsors and collaborators

St. Olavs Hospital

Lead sponsor

Norwegian University of Science and Technology

Collaborator