Study Design and Treatment
This was a prospective, multicenter, open-label, phase III trial randomly assigning patients in a 1:1 ratio to IHP or control (investigator's choice of treatment). Random assignment was performed using permutated blocks with variable size stratified for study site. Inclusion in the trial was recommended as the first-line treatment option by the national Swedish guidelines and as such can be seen as a population-based study.IHP was performed at Sahlgrenska University Hospital, Gothenburg, Sweden. The procedure has previously been described in detail.Patients randomly assigned to the IHP group were not allowed to receive any other antitumoral treatment during follow-up until progression. Patients randomly assigned to the control group received the investigator's choice of treatment according to the discretion of the treating physician at each study site. All available treatments including surgery and other experimental treatments were accepted; however, no crossover to IHP was allowed.