Status:
RECRUITING
Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
Norwegian University of Science and Technology
Conditions:
Tumor, Colorectal
Organoids
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 r...
Detailed Description
Objectives: The primary objective of this study is to test the feasibility of using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2040
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT06907342
Start Date
May 23 2025
End Date
September 1 2040
Last Update
May 25 2025
Active Locations (1)
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1
St. Olavs Hospital
Trondheim, Norway