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.
Age 18 or older
ECOG performance status 0 or 1
Obtained informed consent
Acceptable organ function (defined in publicly available protocol)
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
Single group
FOLFOX or FOLFIRI
DrugTreatment allocation from tumouroid readout
Test the feasibility of using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens for patients with metastatic colorectal cancer.
Rate of generating valid\* tumouroid response reports per patient included in the trial. \*A valid tumouroid response report for a sample is defined as a fold-change growth in untreated controls of \> 1, registered on day 5, 6, 7 or 8 and normalised with respect to day 0 or 1.
Test the feasibility of using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens for patients with metastatic colorectal cancer.
Rate of generating valid\* tumouroid response reports per patient with obtained tumour sample. \*A valid tumouroid response report for a sample is defined as a fold-change growth in untreated controls of \> 1, registered on day 5, 6, 7 or 8 and normalised with resepect to day 0 or 1.
Test the feasibility of using a functional precision medicine platform to select oxaliplatin-based versus irinotecan-based chemotherapy regimens for patients with metastatic colorectal cancer.
What is the time from referral to start of allocated treatment
Describe the tumour response to treatment using RECIST v.1.1
Objective Response Rate (ORR)
Describe the tumour response to treatment using RECIST v.1.1
Disease Control Rate (DCR)
Describe the tumour response to treatment using RECIST v.1.1
Clinical Benefit Rate (CBR), defined as the percentage of patients who had a complete response, partial response, or had stable disease for 6 months or more
Describe the tumour response to treatment using RECIST v.1.1
Duration of Response (DoR)
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St. Olavs Hospital
Lead sponsor
Norwegian University of Science and Technology
Collaborator
