A phase II, open label, multicenter trial investigating Irinotecan plus cetuximab rechallenge compared with trifluridine/tipiracil plus bevacizumab as third line treatment in circulating tumor DNA molecularly selected metastatic colorectal cancer: the ROMANCE-GOIM trial

Condition studied

metastatic colorectal cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

ORR by RECIST 1.1 defined as the proportion of patients who have a partial or complete response to therapy. An external radiology department will receive the images of radiological re-evaluations from the participating sites. The imaging will be assessed by a blind operator

Endpoint detail

1. PFS defined as the time from random assignment in the clinical trial to disease progression or death from any cause., 2. OS defined as the interval from enrollment to death for every cause., 3. The safety profile of the trial drugs as measured by the incidence of AEs evaluated using the NCI- CTCAE version 5.0 (CTCAE v 5.0), SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS, 4. Quality of life (QoL) questionnaire (EORTC QLQ-C30)