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RecruitingPhase 2NCT06907342

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

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

Sponsor

St. Olavs Hospital

Enrollment

148 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal CancerFirst-line TreatmentOrganoidsTumor, ColorectalTumoroidCore Needle Biopsy

Summary

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

Min Age: 18 Years

Inclusion Criteria14

  • 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

Exclusion Criteria22

  • 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

Interventions

DRUGFOLFOX or FOLFIRI

Treatment allocation from tumouroid readout

Locations(1)

St. Olavs Hospital

Trondheim, Norway

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NCT06907342

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