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

NCT06907342 | Recruiting Phase 2

• 1 other identifier: 2024-517677-25-00
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 1 month

• 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.

  Up to 1 month

• 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

  Up to 1 month

Secondary Outcomes (8)

• Describe the tumour response to treatment using RECIST v.1.1

  Up to 48 months

• Describe the tumour response to treatment using RECIST v.1.1

  Up to 48 months

• Describe the tumour response to treatment using RECIST v.1.1

  Up to 48 months

• Describe the tumour response to treatment using RECIST v.1.1

  Up to 48 months

• Assess progression free survival

  Up to 5 years

Study Arms (1)

Treatment cohort

EXPERIMENTAL

FOLFOX or FOLFIRI based on readout from patient-derived tumouroids (via biopsy)

Drug: FOLFOX or FOLFIRI

Interventions

FOLFOX or FOLFIRI DRUG

Treatment allocation from tumouroid readout

Treatment cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Patient has metastatic or primary lesion available for biopsy
• Patient has measurable or evaluable disease per RECIST (version 1.1)
• Patient is eligible for full (100%) chemotherapy doses at first treatment cycle
• Treatment with chemotherapy can be scheduled within 28 days from referral

You may not qualify 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 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
• 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

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St. Olavs Hospital

Trondheim, Norway

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Folfox protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: April 2, 2025
• Study Start: May 23, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2040
• Last Updated: May 25, 2025

Record last verified: 2025-03

Locations

NO (1)