Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma
OBJECTIVES:
- To determine if immediate versus deferred nephrectomy has an effect on disease control
in patients with resectable, synchronous, metastatic renal cell carcinoma treated with
sunitinib malate.
- To identify potential response criteria based on histopathology and molecular research
on tumor tissue.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO performance
status (0 vs 1), number of metastatic sites (1 vs 2 or more), and institution. Patients are
randomized to 1 of 2 treatment arms.
- Arm I (immediate nephrectomy): Patients undergo cytoreductive nephrectomy. Beginning 4
weeks after surgery, patients receive oral sunitinib malate once daily on days 1-28.
Treatment with sunitinib malate repeats every 6 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity.
- Arm II (deferred nephrectomy): Patients receive oral sunitinib malate once daily on
days 1-28. Treatment repeats every 6 weeks for 3 courses in the absence of disease
progression or unacceptable toxicity. About 1 day after completion of sunitinib malate,
patients undergo cytoreductive nephrectomy. Patients then receive oral sunitinib malate
once daily on days 1-28. Treatment repeats every 6 weeks for 2 courses in the absence
of disease progression or unacceptable toxicity.
Some patients undergo tumor tissue collection at baseline and at time of surgery to assess
possible differences in gene expression. Patients also undergo blood sample collection
periodically to evaluate the potential impact of serum proteins on the clinical outcome.
Samples are then stored for future studies.
After completion of study treatment, patients are followed periodically.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Overall progression-free survival
No
Axel Bex
Study Chair
The Netherlands Cancer Institute
Belgium: Ethics Committee
EORTC-30073
NCT01099423
April 2010
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