The study compare the standard treatment with nephrectomy + sunitinib to treatment with sunitinib alone without nephrectomy. This study will be the first trial on this competitive context
The 2 previous studies on the impact of nephrectomy (EORTC, SWOG) in metastatic renal cell carcinoma have justified recommendation to initial nephrectomy for patients presenting with metastatic renal cell carcinoma. But these studies were performed at the time of immunotherapy. The objective is Evaluation of the importance of nephrectomy in patients with metastatic renal cell carcinoma treated with sunitinib (AA) Arm A : Nephrectomy followed by Sunitinib Arm B : Sunitinib alone Sunitinib will be administrated orally daily for 4 weeks followed by a 2 week rest( schedule 4/2), 6 weeks are considered as a cycle The starting dose will be 50 mg daily with provision for dose reduction based on tolerability Patient will be treated until disease progression or unacceptable toxicity occurrence or withdraw.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
452
Current surgery
Sunitinib alone without nephrectomy
Hopital Necker
Paris, France
The primary endpoint is overall survival.
Time frame: starting at 4 months
Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria
Time frame: Starting at 4 months
Clinical benefit (complete response, partial or stable for at least 12 weeks).
Time frame: Starting at 4 months
Progression-Free Survival
Time frame: Starting at 4 months
Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy
Time frame: Starting at 4 months
Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy
Time frame: Starting at 4 months
Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy
Time frame: Starting at 4 months
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