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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.

Principal Investigators

Dr. Naomi B. Haas, Dr Robert Uzzo, and Dr. Keith Flaherty, ECOG; Dr. Christopher Kane, CALGB; Dr. Christopher Wood, SWOG; and Dr. Michael Jewett, NCIC Clinical Trials Group.

Dr. Naomi B. Haas

Dr. Naomi B. Haas Principal Investigator

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 be receiving the current standard of care for their condition, which is no adjuvant therapy.

Sunitinib and sorafenib are targeted therapies that block cell proliferation and the growth of new blood vessels to tumors (a process called 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 Food and Drug Administration 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.

Study Sites and Contact Information

Study sites in the United States are recruiting patients for this trial. See the list of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.

  • Posted: June 27, 2006