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

A vizsgálat adatai

Ki végzi

St. Olavs Hospital

Azonosító

NCT06907342EU 2024-517677-25-00

A regiszteradat frissítve

2026. július 20.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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.

Bevonási feltételek: 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.

Kizáró feltételek: Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle; Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus; 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; Stroke (including TIA) or acute myocardial infarction within 6 months before the first dose of study treatment; Recent (<6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic event; Evidence of previous acute hypersensitivity reaction to any component of the treatment; 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; 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; History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on chest computed tomography (CT); History of any disease that may increase the risks associated with study participation; 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; Patient has metastatic MMR deficient/MSI adenocarcinoma; ECOG performance status 2 or worse; Breastfeeding; 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; Clinically significant peripheral sensory neuropathy.

ClinicalTrials.gov NCT06907342 · EU CTIS 2024-517677-25-00