Correlation of Pathologic Findings After Neo-adjuvant Sorafenib With Results of Diffusion-Weighted Magnetic Resonance Imaging in Patients With Locally Advanced or Metastatic Clear Cell Renal Cell Carcinoma
- To demonstrate the feasibility and safety of sorafenib tosylate when given prior to
nephrectomy or metastasectomy.
- To evaluate the ability of diffusion-weighted magnetic resonance imaging (DW-MRI) to
detect early and ongoing microstructural changes in primary and metastatic renal cell
carcinoma lesions during neoadjuvant therapy with sorafenib tosylate.
- To correlate early and ongoing microstructural changes in primary and metastatic renal
cell carcinoma lesions with pathologic and clinical findings at the time of nephrectomy
- To evaluate the ability of changes in DW-MRI to predict subsequent favorable response
to treatment (complete or partial response or stable disease) after 4 weeks of therapy.
OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Patients then
undergo a nephrectomy or metastasectomy in week 5. Patients with residual metastatic disease
may continue sorafenib tosylate twice daily and undergo a diffusion-weighted MRI (DW-MRI)
every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo a DW-MRI of the abdomen and pelvis at baseline and prior to week 5 to
evaluate microstructure tumor changes and to allow for prediction of sorafenib tosylate
benefit. DW-MRI results are correlated with surgical and pathologic findings obtained at
Resected tumor tissue are analyzed for vascular density and to distinguish apoptotic cell
death from necrotic cell death via immunohistochemistry and to measure apoptotic cell death
via TUNEL assay.
After completion of study treatment, patients are followed every 3 months for 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MRI apparent diffusion coefficients (ADC) at baseline and week 5
Patients will undergo a DW-MRI of the pelvis at baseline and prior to week 5 to evaluate microstructure tumor changes and to allow for prediction of sorafenib tosylate benefit
Baseline and week 5
Timothy M. Kuzel, MD
Robert H. Lurie Cancer Center
United States: Food and Drug Administration
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|