A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
NCT00375674
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- 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
- 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
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Descriptive Information | ||||
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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 ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
Condition ICMJE | Kidney Neoplasms | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 | Completed | |||
Actual Enrollment ICMJE | 674 | |||
Original Enrollment ICMJE | 228 | |||
Actual Study Completion Date ICMJE | September 7, 2017 | |||
Actual Primary Completion Date | April 7, 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, China, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Poland, Slovakia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States | |||
Removed Location Countries | Austria, Czech Republic | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00375674 | |||
Other Study ID Numbers ICMJE | A6181109 2006-004024-37 ( EudraCT Number ) S-TRAC ( Other Identifier: Alias Study Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |