Sixteen participants did not meet eligibility criteria to proceed into the full trial and nine declined to participate further.
The only subtype to meet the response criteria to proceed to stage 2 of the enrolment based on a Simon two-stage design was the adipocytic tumor.
A-priori criteria to proceed to a larger definitive trial were established upfront in consultation with the Trial Steering Committee and are detailed below.
In conclusion, the combination of gemcitabine and bexarotene did not meet the criteria to proceed to the second stage of the trial design, albeit that the majority of patients initially demonstrated some clinical response and improvement in QoL while on treatment.
Dropouts are not considered recurrences, but all of the listed reasons could potentially be referring to treatment failure, especially given the lack of detail reported of the response criteria necessary to proceed to the next phase.
The major finding to emerge from this study was that although 80.0% of patients demonstrated a reduction in mSWAT score with the combination of bexarotene and gemcitabine the objective responses and duration of responses were surprisingly poor at 24 weeks and did not meet the predefined criteria set to proceed to the second stage of the trial.
For either schedule, if criteria were met to proceed to Stage 2, then ~26 additional patients would be added to that treatment schedule and if 9 or more of the total 46 patients achieved a response, then the study would be considered successful.
In this case, uncertainty about roles, ground rules, criteria and how to proceed (what Steinfeld [ 42] refers to as 'environmental uncertainty') seems to have resulted in the adoption by some members of a writing style that is characteristically formal and impersonal.
This paper deals with the main issue of quantitative and qualitative criteria definition, in order to proceed to such a full road condition assessment.
No decision has been made on whether to proceed, said Criteria CaixaCorp, which owns 28.5 percent of Abertis, and Actividades de Construcción y Servicios, which has a 25.8 percent stake.
