Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma (SURF)
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|ClinicalTrials.gov Identifier: NCT02689167|
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : November 29, 2021
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 "
|Condition or disease||Intervention/treatment||Phase|
|Kidney Neoplasms Metastatic Renal Cell Cancer||Drug: Sunitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label, Randomised Multi-centre Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma|
|Actual Study Start Date :||February 19, 2016|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||February 2024|
Active Comparator: Arm A 4/6
Sunitinib 37.5 mg/day; regimen 4/6 (Marketing Authorisation Indication) 4 weeks "on " alternating with 2 weeks "off "
Experimental: Arm B 2/3
Sunitinib 50 mg/day; regimen 2/3 (experimental arm) 2 weeks "on " alternating with 1 week "off "
- MDT (median duration of treatment) [ Time Frame: 12 mo ]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.
- PFS (progression-free survival) [ Time Frame: 12 months ]To estimate progression-free survival in patients included in each of the groups and in the overall population included in this study.
- OS (overall survival) [ Time Frame: 30 months ]To estimate overall survival in patients included in each of the groups and in the overall population included in this study.
- duration of sunitinib post randomization [ Time Frame: 12 months ]Estimation of the time between date of randomization and sunitinib arrest (for any reason) in the two treatment arms.
- time to randomization [ Time Frame: 4 months ]To estimate the time to randomization defined as the time between the date of sunitinib initiation and the date of randomization.
- ORR (objective response rate) [ Time Frame: 6 months ]To measure the objective response rate according to RECIST 1.1 criteria.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 24 months ]To assess safety profile before and after randomization.
- QOL (quality of life) [ Time Frame: 24 months ]To assess health-related quality of life since sunitinib is started (before randomization, at the time of randomization and after randomization)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689167
|Besancon, Franche-Comté, France, 25030|
|Principal Investigator:||antoine thiery-vuillemin, MD PhD||Centre Hospitalier Universitaire de Besancon|