S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery (S0931)
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ClinicalTrials.gov Identifier: NCT01120249 |
Recruitment Status :
Active, not recruiting
First Posted : May 10, 2010
Results First Posted : March 20, 2024
Last Update Posted : March 20, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | May 7, 2010 | |||
First Posted Date ICMJE | May 10, 2010 | |||
Results First Submitted Date ICMJE | November 9, 2023 | |||
Results First Posted Date ICMJE | March 20, 2024 | |||
Last Update Posted Date | March 20, 2024 | |||
Actual Study Start Date ICMJE | April 1, 2011 | |||
Actual Primary Completion Date | July 1, 2023 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
5-year Recurrence-free Survival (RFS) [ Time Frame: 5 years from registration ] To compare 5-year recurrence-free survival in renal carcinoma participants randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy. Recurrence-free survival is defined as From date of registration to date of first documentation of recurrence or death due to any cause. Participants last known to be alive and recurrence-free are censored at date of last contact. Recurrence is defined as positive cytology or biopsy and/or progressively enlarging solid mass as evidenced by CT or MRI scans.
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Original Primary Outcome Measures ICMJE |
Recurrence-free survival | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery | |||
Official Title ICMJE | EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study | |||
Brief Summary | RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage (intermediate high-risk vs very high-risk), histologic subtype (clear cell vs non-clear cell), and performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
Archived tumor tissue, plasma, and whole blood samples may be collected periodically for biomarker analysis and other translational studies. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 8 years. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Kidney Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
1545 | |||
Original Estimated Enrollment ICMJE |
1218 | |||
Estimated Study Completion Date ICMJE | October 15, 2026 | |||
Actual Primary Completion Date | July 1, 2023 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 120 Years (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 | Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01120249 | |||
Other Study ID Numbers ICMJE | S0931 S0931 ( Other Identifier: SWOG ) U10CA032102 ( U.S. NIH Grant/Contract ) NCI-2011-02028 ( Other Identifier: NCI ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | SWOG Cancer Research Network | |||
Original Responsible Party | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office | |||
Current Study Sponsor ICMJE | SWOG Cancer Research Network | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | SWOG Cancer Research Network | |||
Verification Date | March 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |