No objective response was observed in either group and the study was closed after the first step of accrual with the conclusion of a lack of therapeutic activity of single-agent temozolomide in patients with stage IV NSCLC.
Originally planned for 250 patients, the study was closed because of poor accrual with 81 evaluable patients, including 41 patients who received vinorelbine and 40 patients who received taxane.
Entry diagnoses were confirmed independently by two study team members after the study was closed and all required clinical data was completed and submitted by the sites.
If the participant did not return to the study before the study was closed, she was considered lost to follow-up at closeout.
If the participant did not return to the study before the study was closed, she was considered lost to follow-up.
The target sample size was 29 subjects, but the study was closed after enrollment of 19 subjects due to slow accrual.
Thus the study was closed to enrolment.
Thus, the study was closed ahead of schedule.
Unfortunately, the study was closed early due to a 12.5% incidence of engraftment failure.
However, after new unacceptable cosmesis developed in seven patients, the study was closed early.
The study was closed because of excessive toxicity, and a maximum tolerated regimen was not identified.
