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

Launched by ST. OLAVS HOSPITAL · Mar 26, 2025

Keywords

ClinConnect Summary

The COSENSE-1 trial is a research study that aims to find out which type of chemotherapy works best for patients with metastatic colorectal cancer that cannot be surgically removed. Specifically, it is looking at two types of chemotherapy: one that includes oxaliplatin and another that includes irinotecan. The goal is to see if a personalized medicine approach, which considers the unique characteristics of each patient's cancer, can help select the most effective treatment. This study is for adults aged 18 and older who have been diagnosed with a specific type of colorectal cancer that is stable and has not shown certain genetic markers indicating a different treatment path.

To participate in this trial, patients must have measurable cancer that is confirmed by a biopsy and should be in good overall health, meaning they can perform daily activities without major limitations. They also need to agree to use effective birth control if they are of child-bearing age. If eligible, participants can expect to receive either of the chemotherapy regimens and will be closely monitored throughout the study to assess how well the treatment is working. It's important to note that this trial is not yet recruiting participants, so there may be a wait before it starts.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• General conditions:
• • 1. Age 18 or older
• • 2. ECOG performance status 0 or 1
• • 3. Obtained informed consent
• • 4. Acceptable organ function (defined in publicly available protocol)
• • 5. Women of child-bearing potential and men must agree to use highly effective contraception (defined in publicly available protocol)
• Disease and treatment specific conditions:
• • 6. Histologically confirmed pMMR/MSS adenocarcinoma originating from the colon or rectum
• • 7. Unresectable metastatic disease (not amenable to radical surgery of the cancer disease at the time of study inclusion)
• • 8. Patient has metastatic or primary lesion available for biopsy
• • 9. Patient has measurable or evaluable disease per RECIST (version 1.1)
• • 10. 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)
• • 11. Patient is eligible for full (100%) chemotherapy doses at first treatment cycle
• • 12. Treatment with chemotherapy can be scheduled within 28 days from referral
• Exclusion Criteria:
• • 1. Patient has metastatic MMR deficient/MSI adenocarcinoma
• • 2. Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle
• • 3. 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
• • 4. ECOG performance status 2 or worse
• • 5. Pregnancy or planned pregnancy during the study period, due to the risks of drug treatment to a developing foetus
• • 6. Breastfeeding
• • 7. Patients with psychological, geographical, familial or sociological conditions that can prevent compliance with the study protocol
• • 8. 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
• • 9. Patient fulfils any of the contraindications listed in the SmPC of the relevant IMP
• • 10. Treatment cannot be scheduled within 28 days from referral
• Medical history:
• • 11. Partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency
• • 12. Evidence of CNS metastasis
• • 13. Unresolved toxicities of a previous systemic treatment that, in the opinion of the physician, make the patient unfit for inclusion
• • 14. Antitumoural treatment ≤ 30 days before inclusion. Hormonal substitutive treatment is allowed
• • 15. 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
• • 16. Stroke (including TIA) or acute myocardial infarction within 6 months before the first dose of study treatment
• • 17. Clinically significant peripheral sensory neuropathy
• • 18. Recent (\<6 months before the start of study treatment) pulmonary embolism, deep vein thrombosis, or another significant thromboembolic event
• • 19. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on chest computed tomography (CT)
• • 20. Evidence of previous acute hypersensitivity reaction to any component of the treatment
• • 21. History of any disease that may increase the risks associated with study participation