Extrait

The aim of the STAR trial is to evaluate the use of a Modified sunitinib schedule compared to the Standard sunitinib schedule, in patients with locally advanced and/or metastatic renal cancer. The trial has three stages and should the trial not meet predetermined endpoints in its initial 2 stages (A and B), then recruitment will not continue to the third stage (stage C). Stage A: To establish the feasibility of performing the trial in terms of recruitment and whether the final required sample size is likely to be achieved and in a timely manner. Average monthly recruitment between months 10-21 inclusive will be used to determine this. Stage B: To provide an initial indication that the Modified sunitinib schedule (with planned treatment breaks) is not significantly worse than the Standard sunitinib schedule, by comparing the time until participants permanently stop sunitinib in each treatment arm. Stages A B and C: To show that the Modified sunitinib schedule is not wors

Critère d'inclusion

• Metastatic and/or locally advanced Renal Clear Cell Carcinoma

Liens

• isrctn
• ictrp
• ictrp
• euctr