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A Phase III Study of Adjuvant Sunitinib versus Placebo in Patients with High-Risk Renal Cell Carcinoma
[Protocol 07-086]
- Full Title :
- SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS AT HIGH RISK OF RECURRENT RCC
- Purpose :
The standard treatment for renal cell carcinoma (RCC, a type of kidney cancer) that has been surgically removed is not to give any additional treatment unless the cancer returns. Sunitinib (Sutent®) is a drug that is approved for the treatment of RCC. It works by inhibiting the growth of blood vessels (angiogenesis) that tumors need to receive nutrition and to spread to other parts of the body. The drug, which is taken orally (by mouth), may also slow the growth and division of cancer cells.
In this study, researchers are evaluating the effectiveness of giving one year of sunitinib (every 4 weeks, followed by a 2-week break) in patients with RCC that has been surgically removed but has a high risk of returning. Patients will be randomly assigned to receive either sunitinib or a placebo.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of renal cell carcinoma that has been surgically removed and is determined to be at high risk of recurrence.
- Patients may not have had any systemic therapy (such as chemotherapy or immunotherapy) for RCC, nor any prior treatment with anti-angiogenic drugs.
- Patients must not be confined to a bed or chair for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Robert Motzer at 646-422-4312.
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