Organoids to Predict Treatment response In mCRC (OPTIC)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 193

Inclusion Criteria

1- Patients with histologically proven metastatic colorectal cancer who will
receive palliative standard of care systemic treatment, including, but not
limited to:
1.1. Capecitabine +/- Bevacizumab (CAP(-B))
1.2. Capecitabine + oxaliplatin +/- Bevacizumab (CAPOX(-B))
1.3. 5FU/LV + oxaliplatin + Bevacizumab (FOLFOX-B)
1.4. 5FU/LV + irinotecan + Bevacizumab (FOLFIRI-B)
1.5. 5FU/LV + oxaliplatin + irinotecan + bevacizumab (FOLFOXIRI-B)
1.6. FOLFIRI + panitumumab (FOLFIRI-P)
1.7. FOLFOX + panitumumab (FOLFOX-P)
1.8. Anti-EGFR monotherapy (cetuximab or panitumumab),
1.9. Irinotecan (IRI)
1.10. Trifluridine + tipiracil hydrochloride (TAS-102)
1.11. Encorafenib + cetuximab
1.12. Treatments outside the above mentioned standard of care regimens
(including immune checkpoint inhibitors for dMMR mCRC patients) can be
considered, but must be approved by the OPTIC P.I. prior to including patients.

2- Patient is included in PLCRC and has signed informed consent to be asked for
future studies and blood withdrawal within PLCRC. , 3- Patients need to have
measurable RECIST CT imaging (according to RECIST 1.1) or evaluable disease.,
4- Metastatic lesion(s), localized outside the bone, of which a biopsy can
safely be obtained as per local guidelines and which is RECIST measurable on CT
imaging., 5- Patients not known with contraindications for lidocaine (or its
derivatives)., 6- Patients age > 18 years, willing and able to comply with the
protocol as judged by the investigator with a signed informed consent.

Exclusion Criteria

- Patients with additional unrelated tumors influencing treatment decision
making, potentially affecting size changes of metastases or competing risk for
survival.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints:<br /><br><br /><br>• Response at first evaluation after treatment with standard of care drugs of<br /><br>the index metastasis that is biopsied for organoid culture as measured by<br /><br>change in size on a CT-scan (continuous variable).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br><br /><br>• Response of the index metastasis at second and/or following evaluations<br /><br>(continuous variable)<br /><br>• Response of the index metastasis dichotomized (< or >20% change in size)<br /><br>• Response at patient level according to RECIST 1.1<br /><br>• Progression-free survival<br /><br>• Repeat above end-points (index metastasis, patient-level response and<br /><br>progression-free survival) for subgroups:<br /><br>1. per treatment line (e.g. 1st, 2nd or 3rd)<br /><br>2. per type of treatment given (e.g. irinotecan, oxaliplatin-containing)<br /><br>• Yield/feasibility of organoid culture</p><br>