Testing a Functional Precision Medicine Approach to Select Chemotherapy for Metastatic Col
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
| Condition(s) | Tumor, Colorectal, Organoids, Tumoroid, Metastatic Colorectal Cancer, Core Needle Biopsy, First-line Treatment |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | St. Olavs Hospital |
| Locations | Trondheim, Norway |
| Start date | 2025-05-23 |
| NCT ID | NCT06907342 |
| Official listing | https://clinicaltrials.gov/study/NCT06907342 |