Metastatic colorectal cancer
Conditions
Interventions
N.A.
Sponsors
UMC Utrecht
Dept. of Medical Oncology
UMC Utrecht
PO Box 85500 (Q04.4.300),
3508 GA Utrecht, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: (Shortened) 1- Patients with histologically proven metastatic colorectal cancer who will receive first line systemic treatment. 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 (26). 4- Metastatic lesion(s) in the liver of which a biopsy can safely be obtained. 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. If patients start a new line of treatment after participation in this trial, they are eligible to participate again. Informed consent, baseline screening and the histological biopsy procedure will have to be repeated.
Exclusion criteria
Exclusion criteria: 1- Patients with additional unrelated tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 • Yield/feasibility of organoid culture | — |
Outcome results
None listed