Study design and participants
ONCOLOGY, RECRUITMENT, COLORECTAL CANCER, METASTASES
This phase 2, single-center, open-label, historically controlled trial enrolled patients with non-resectable metastases from colorectal cancer. The selection criteria included patients at age ≥ 18 years, Eastern Cooperative Oncology Group performance status (PS) = 0–2, adequate organ function with absolute neutrophil count ≥ 1.5 × 10All patients provided written informed consent, and the trial was conducted following the guidelines for Good Clinical Practice and the Declaration of Helsinki. The Danish Medicines Agency (EudraCT no 2017-000456-26) and The Regional Committee on Health Research Ethics for Southern Denmark (S-2017-0028) approved the protocol. In February and September 2019, amendments adding vemurafenib, temozolomide, binimetinib, and encorafenib were approved. The trial was prospectively registered with ClinicalTrials.gov (NCT03251612) on August 16, 2017, before the inclusion of the first patient. The protocol sponsor reviewed the study feasibility, biopsy, logistics, and in vitro testing after enrolling ten patients to recommend continued recruitment, protocol amendment, or retraction of the study.