Adjuvant Therapy for Kidney Cancer
Name of the Trial
Phase III Randomized Study of Adjuvant Sunitinib Malate Versus Sorafenib in Patients with Resected Renal Cell Carcinoma (ECOG-E2805). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E2805.
Drs. Naomi B. Haas, Robert Uzzo, and Keith Flaherty, ECOG; Dr. Christopher Kane, CALGB; Dr. Christopher Wood, SWOG; and Dr. Michael Jewett, National Cancer Institute of Canada Clinical Trials Group
Why This Trial Is Important
More than 30,000 Americans are expected to be diagnosed with kidney cancer (renal cell carcinoma) in 2006. Surgery is the primary treatment for most cases of kidney cancer. While surgery alone often cures patients with early-stage disease, individuals with more advanced disease have an increased risk of cancer recurrence after surgery.
In this trial, patients who have tumors that can be surgically removed and who are at high risk for recurrence will be given sunitinib (Sutent), sorafenib (Nexavar), or a placebo as postoperative (adjuvant) therapy. Patients given the placebo will receive the current standard of care for their condition, which is no adjuvant therapy.
Sunitinib and sorafenib are targeted therapies that block cell proliferation and angiogenesis. Angiogenesis is important for the growth and spread of malignant kidney tumors, and blocking it may help prevent the growth of cancer cells that remain after surgery.
"Both sunitinib and sorafenib were approved recently by the FDA to treat metastatic kidney cancer," said Dr. Haas. "If either of these agents helps improve disease-free survival following complete surgical removal of the tumors in patients who are at high risk for recurrence, it will lead to a change in clinical practice."
Who Can Join This Trial
Researchers seek to enroll 1,332 patients aged 18 and over with renal cell carcinoma that can be surgically removed and who are determined to be at high risk for recurrence. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/ECOG-E2805.
Study Site and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts at http://cancer.gov/clinicaltrials/ECOG-E2805, or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.