NCT00375674

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 674 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Kidney Neoplasms

Interventions

Type	Name	Description
DRUG	Sunitinib malate	sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
OTHER	Placebo	Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent

Timeline

• Start date: 2007-08-01
• Primary completion: 2016-04-07
• Completion: 2017-09-07
• First posted: 2006-09-13
• Last updated: 2018-09-21
• Results posted: 2017-08-18

Locations

115 sites across 22 countries: United States, Australia, China, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Malaysia, Mexico, Poland, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom