A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

Completed · Phase 3 · Has a placebo group

Conditions studied: Kidney Neoplasms

In brief

To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

Key facts

Study ID

NCT00375674

Run by

Pfizer

People needed

674

Starts

2007-08-01

Expected to finish

2017-09-07

Last updated by the study team

2018-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• High risk renal cancer per modified UISS criteria
• Eastern Cooperative Oncology Group (ECOG) 0-2
• predominant clear cell histology
• No prior anti-cancer treatment
• Kidney tumor has been removed
• No evidence of macroscopic disease following surgery

You may not qualify if…

• Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
• Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
• known HIV or Hepatitis
• any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration

Where it is running

• UCLA Clark Urology Center — Los Angeles, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• The Emory Clinic, Inc — Atlanta, Georgia, United States
• Hematology and Oncology Specialists, LLC — Marrero, Louisiana, United States
• Hematology and Oncology Specialists, LLC — Metairie, Louisiana, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States
• Intermountain Medical Center — Murray, Utah, United States
• Monash Medical Centre - Moorabin Campus — East Bentleigh, Victoria, Australia
• Urology Department, Sun Yet-Sen University Cancer Center — Guangzhou, Guangdong, China
• The first affiliated hospital of Soochow university/Department of Urology — Suzhou, Jiangsu, China
• Fudan University Cancer Hospital, Department of Urology — Shanghai, Shanghai Municipality, China
• Urology Department, Renji Hospital,Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
• Department of Urology, Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China
• Department of Urology, the Second Affiliated Hospital of Zhejiang University College of Medicine — Hangzhou, Zhejiang, China
• Cancer Institute & Hospital, CAMS — Beijing, China
• Department of Urology,Peking University First Hospital — Beijing, China
• Chinese PLA General Hospital/Urology Department — Beijing, China
• Urology Department, South-Western Hospital, 3rd Military Medical University. — Chongqing, China
• Huashan Hospital Fudan University — Shanghai, China
• Tianjin Oncology Hospital, urology department — Tianjin, China
• Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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