colorectal cancer colorectal carcinoma
Conditions
Interventions
None listed
Sponsors
UMC Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: - Patients with additional unrelated tumors influencing treatment decision making, potentially affecting size changes of metastases or competing risk for survival.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: • Response at first evaluation after treatment with standard of care drugs of the index metastasis that is biopsied for organoid culture as measured by change in size on a CT-scan (continuous variable). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: • Response of the index metastasis at second and/or following evaluations (continuous variable) • Response of the index metastasis dichotomized (20% change in size) • Response at patient level according to RECIST 1.1 • Progression-free survival • Repeat above end-points (index metastasis, patient-level response and progression-free survival) for subgroups: 1. per treatment line (e.g. 1st, 2nd or 3rd) 2. per type of treatment given (e.g. irinotecan, oxaliplatin-containing) • Yield/feasibility of organoid culture | — |
Countries
Netherlands
Outcome results
None listed