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Contact Information

General Phone Number
888-844-8447
216-844-8447
Mailing Address
11100 Euclid Avenue
Cleveland, OH 44106
Clinical Trials

Trial Name:

E 2805
Intro: A Randomized, Double Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma
Condition:
Description: This study will determine if either Sunitinib or Sorafenib can prevent recurrence of kidney cancer and compare the effects of the Sunitinib and the Sorafenib with placebo to see which is better. Patients will take 2 tablets of Sorafenib of placebo twice a day for 6 weeks for approximately one year and 4 capsules of Sunitinib or placebo once a day for 4 weeks followed by a 2 week break for approximately one year. Patients can be registered before or after surgery.
Criteria:
  1. Age > 18 years
  2. If registered presurgery: Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent
  3. If registered post surgery: No evidence of residual or metastatic cancer after surgery
  4. Must be no less than 3 weeks and no more than 10 weeks from surgery at randomization
  5. Patients with no prior anti-cancer therapy are permitted in either the adjuvant or neoadjuvant setting. This includes metastectomy for renal cell carcinoma, or radiation therapy to the renal bed
  6. Patients must have histological or cytological confirmed renal cell carcinoma T1B (Fuhrman grade 3-4), T2, T3 and T4 with N0-2 and must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) by either open or laparoscopic technique
  7. ECOG performance status 0 – 2
  8. Patients must have normal bone marrow, liver and kidney function
  9. No pre-existing thyroid abnormalities
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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