Immediate Surgery or Surgery After Sunitinib Malate in Treating Patients With Metastatic Kidney Cancer

Official Title

Randomized Phase III Trial Comparing Immediate Versus Deferred Nephrectomy in Patients With Synchronous Metastatic Renal Cell Carcinoma

Summary:

RATIONALE: Sunitinib malate may stop the growth of tumour cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumour. Giving sunitinib malate before surgery may make the tumour smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumour cells that remain after surgery. It is not yet known whether undergoing immediate surgery or surgery after sunitinib malate is more effective in treating patients with metastatic kidney cancer. PURPOSE: This randomized phase III trial is studying immediate surgery to see how well it works compared with surgery after sunitinib malate in treating patients with metastatic kidney cancer.

Trial Description

Primary Outcome:

• Overall progression-free survival

Secondary Outcome:

• Overall survival
• Morbidity
• Overall response to treatment in the deferred nephrectomy arm including the proportion of patients who become unresectable
• Effect of nephrectomy on early progression in both arms

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 tumour tissue.

OUTLINE:

This is a multicentre 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 tumour 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.

View this trial on ClinicalTrials.gov