Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off " As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1: * Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off " * Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
CHU Besancon
Besançon, Franche-Comté, France
MDT (median duration of treatment)
The primary objective of this study is to estimate the median duration of treatment in each treatment group (arm A vs arm B) calculated from sunitinib initiation.
Time frame: 12 mo
PFS (progression-free survival)
To estimate progression-free survival in patients included in each of the groups and in the overall population included in this study.
Time frame: 12 months
OS (overall survival)
To estimate overall survival in patients included in each of the groups and in the overall population included in this study.
Time frame: 30 months
duration of sunitinib post randomization
Estimation of the time between date of randomization and sunitinib arrest (for any reason) in the two treatment arms.
Time frame: 12 months
time to randomization
To estimate the time to randomization defined as the time between the date of sunitinib initiation and the date of randomization.
Time frame: 4 months
ORR (objective response rate)
To measure the objective response rate according to RECIST 1.1 criteria.
Time frame: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To assess safety profile before and after randomization.
Time frame: 24 months
QOL (quality of life)
To assess health-related quality of life since sunitinib is started (before randomization, at the time of randomization and after randomization)
Time frame: 24 months
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