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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 12, 2006
Last updated: December 19, 2016
Last verified: December 2016
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.

Condition Intervention Phase
Kidney Neoplasms Drug: Sunitinib malate Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Disease-free survival comparing sunitinib with placebo [ Time Frame: 36 months ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 10 years ]
  • Safety [ Time Frame: 12 months ]
  • Tolerability [ Time Frame: 12 months ]
  • Patient-reported outcomes [ Time Frame: 12 months ]

Estimated Enrollment: 720
Study Start Date: August 2007
Estimated Study Completion Date: August 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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.
Placebo Comparator: B 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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00375674

  Show 115 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pfizer Identifier: NCT00375674     History of Changes
Other Study ID Numbers: A6181109
2006-004024-37 ( EudraCT Number )
S-TRAC ( Other Identifier: Alias Study Number )
Study First Received: September 12, 2006
Last Updated: December 19, 2016

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on July 25, 2017