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 currently recruiting participants.

Verified May 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00375674

First received: September 12, 2006

Last updated: May 6, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2006

Last Updated Date

May 6, 2013

Start Date ^ICMJE

July 2007

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Disease-free survival comparing sunitinib with placebo [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Disease-free survival comparing sunitinib with placebo

Change History

Complete list of historical versions of study NCT00375674 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Overall Survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
Safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Patient-reported outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Relapse-free Survival Overall Survival Patient-reported outcomes Safety

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Neoplasms

Intervention ^ICMJE

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

Study Arm (s)

Experimental: A
Intervention: Drug: Sunitinib malate
Placebo Comparator: B
Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

720

Estimated Completion Date

June 2017

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com

Location Countries ^ICMJE

United States, Australia, China, Colombia, Czech Republic, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00375674

Other Study ID Numbers ^ICMJE

A6181109

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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