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

Sponsor
St. Olavs Hospital
Study ID
NCT06907342
Phase
PHASE2
Status
Recruiting
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Conditions

  • Core Needle Biopsy
  • First-line Treatment
  • Metastatic Colorectal Cancer
  • Organoids
  • Tumor, Colorectal
  • Tumoroid

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FOLFOX or FOLFIRI — DRUG
    Treatment allocation from tumouroid readout

Study Details

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.

Key Dates

First listed
Apr 2, 2025
Start date
May 23, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Sep 30, 2040

Study Design

Enrollment
148 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment cohort
    FOLFOX or FOLFIRI based on readout from patient-derived tumouroids (via biopsy)

Primary Outcome Measure

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. [ Time Frame: Up to 1 month ]

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