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New treatment option for Tumor, Colorectal
Official title Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Colorectal Cancer (COSENSE-1)
ClinicalTrials.gov ID: NCT06907342
What this study is testing
What is FOLFOX or FOLFIRI?
FOLFOX or FOLFIRI is an investigational medicine, being studied as a potential treatment for tumor, colorectal.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General conditions:
- Age 18 or older
- ECOG performance status 0 or 1
- Obtained informed consent
- Acceptable organ function (defined in publicly available protocol)
You likely can't join 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...
- 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
See the full eligibility criteria
- 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...
- Patient is eligible for full (100%) chemotherapy doses at first treatment cycle
- Treatment with chemotherapy can be scheduled within 28 days from referral
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Trondheim, Norway
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Trondheim, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.