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

Recruiting now · Phase 2

Conditions studied: Tumor, Colorectal, Organoids, Tumoroid, Metastatic Colorectal Cancer, Core Needle Biopsy, First-line Treatment

In brief

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.

Key facts

Study ID: NCT06907342
Run by: St. Olavs Hospital
People needed: 148
Starts: 2025-05-23
Expected to finish: 2040-09-01
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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
Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus
Breastfeeding
Patients with psychological, geographical, familial or sociological conditions that can prevent compliance with the study protocol
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
Patient fulfils any of the contraindications listed in the SmPC of the relevant IMP
Treatment cannot be scheduled within 28 days from referral
Medical history:
Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
Evidence of CNS metastasis
Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion
Antitumoural treatment ≤ 30 days before inclusion. Hormonal substitutive treatment is allowed
Preexisting significant cardiovascular disease including uncontrolled/unstable or symptomatic angina, uncontrolled atrial or ventricular arrythmias, LVEF known to be < 40% or symptomatic congestive heart failure
Stroke (including TIA) or acute myocardial infarction within 6 months before the first dose of study treatment
Clinically significant peripheral sensory neuropathy
Recent (<6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic event
History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on chest computed tomography (CT)
Evidence of previous acute hypersensitivity reaction to any component of the treatment
History of any disease that may increase the risks associated with study participation

Where it is running

St. Olavs Hospital — Trondheim, Norway (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.