Perioperative Systemic Therapy Versus Cytoreductive Surgery and HIPEC Alone for Resectable Colorectal Peritoneal Metastases: Patient-Reported Outcomes of a Randomized Phase II Trial.

"Disclosures Prof. I.H.J.T. de Hingh received grants (paid to institute) from QP&S/RanD Biotech for research unrelated to the submitted work. Prof. Dr. P.J. Tanis received an unrestricted research grant from Allergan (LifeCell) unrelated to the submitted work. Prof. C.J.A. Punt has an advisory role for Nordic Pharma. All remaining authors have declared no conflicts of interest."

"Funding This work was supported by the Dutch Cancer Society (Grant Number 10795); and Hoffman-La Roche (Grant Number ML39718)."

"CAIRO6 is an investigator-initiated, parallel-group, open-label, phase II–III, randomized, superiority trial conducted in all nine Dutch tertiary hospitals for the surgical treatment of colorectal peritoneal metastases. The trial is approved by a central ethics committee (MEC-U, Nieuwegein, the Netherlands, R16.056) and the institutional review boards of all participating hospitals. The trial is registered (Clinicaltrials.gov: NCT02758951). The trial protocol and the feasibility and safety data of the phase II trial (i.e., mortality, morbidity, surgical details, hospital stay) have been previously published. Therefore, only brief descriptions of eligible patients, randomization procedures, and interventions are provided."