Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma (PREINSUT)
The aim of this study is to identify and/or validate biomarkers and imaging markers to predict and monitor the activity of a new class of therapeutic agents called antiangiogenics for the treatment of metastatic renal cell carcinoma (mRCC). Suntinib, approved for this indication, will be administred before and after nephrectomy and biomarkers sampling and imaging will be operated to monitor the activity and identify prognostic factors in mRCC.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Biological, Pathological and Imagery Markers in the First-line Treatment of Metastatic Clear-cell Renal Cell Carcinoma With Sunitinib BEFORE and AFTER Nephrectomy|
- To evaluate the prognostic value of several factors (biomarkers and imaging) to identify responders [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- To determine the objective response rate after initiation of treatment in the primitive tumour, according to the RECIST criteria. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To assess the pathological response (tumoral extension), Progression Free Survival (PFS) as defined by pProgression Free Survival (PFS) as defined by progression of metastasis, overall survival (OS). [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- To evaluate the correlation between tumor extension as defined by the pathologist and the tumor reduction between initiation of treatment and nephrectomy as measured by CT scan [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To compare marker expression in the biopsy (before treatment) and in the primitive tumor. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To evaluate the ability of investigated biomarkers and VEGF-A gene polymorphisms to be prognostic of the pathological response and of the Progression Free Survival. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- To evaluate the correlation between the imaging obtained with Dynamic Contrast-enhanced CT scan, with contrast-enhanced US and VEGF expression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- To explore the pharmacokinetic of Sunitinib at study state [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- To monitor the potential renal toxicity of Sunitinib [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|SUTENT before nephrectomy||
Drug: Sunitinib (SUTENT)
Sunitinib, SUTENT, 50 mg daily p.o., on schedule 4/2, for 2 cycles. Two weeks of rest prior to surgery (week 11 and 12).
Radical nephrectomy at the end of week 12. Sunitinib 50 mg/d, schedule 4/2, reintroduced 2 weeks after surgery (week 14, may be postponed by one or two weeks if wound healing delay or surgical complications). Treatment until disease progression, unacceptable toxicity or consent withdrawal. Dose reduction depending on the type and severity of toxicity.
At the end of the treatment period patients will be treated at the discretion of the Investigator.
Other Name: Sunitinib (SUTENT)
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00930345
|Paris, France, 75015|
|Principal Investigator:||Stephane OUDARD, MD||Assistance Publique - Hôpitaux de Paris|