S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
- Registration Number
- NCT01120249
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
- Detailed Description
OBJECTIVES:
Primary
* to compare recurrence-free survival in renal carcinoma patients randomly assigned to 54 weeks of everolimus versus 54 weeks of placebo after nephrectomy or partial nephrectomy.
Secondary
* To compare the overall survival of patients treated with everolimus vs placebo.
* To compare qualitative and quantitative toxicity between the two study arms.
* To bank tissue and biologic specimens for future study of molecular biomarkers relevant to the AKT/mTOR and other pathways implicated in the pathogenesis of renal carcinoma and to investigate their potential predictive and prognostic value.
* To bank blood specimens for the future study of the relationship between steady-state trough levels of everolimus and relevant side effects (lymphopenia, infection, hyperglycemia, hypercholesterolemia, hypertriglyceridemia) in patients treated on this study with everolimus.
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.
* Arm I: Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1545
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II placebo Patients receive oral placebo once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. Arm I everolimus Patients receive oral everolimus once daily on days 1-42. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method 5-year Recurrence-free Survival (RFS) 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.
- Secondary Outcome Measures
Name Time Method Frequency and Severity of Toxicities Up to 54 weeks of treatment Number of participants with Grade 3-5 adverse events that are possibly, probably or definitely related to study drug are reported. Measured using CTCAE v4.0.
5-year Overall Survival (OS) 5 years from registration To compare 5-year overall survival in those patients randomized to everolimus versus those randomized to placebo. Overall survival is defined as time from date of registration to date of death due to any cause or patients last known to be alive are censored at their last contact date.
Trial Locations
- Locations (991)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Gulf Coast MBCCOP
🇺🇸Mobile, Alabama, United States
Providence Hospital
🇺🇸Mobile, Alabama, United States
University of South Alabama Mitchell Cancer Institute
🇺🇸Mobile, Alabama, United States
Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States
Arizona Cancer Center at UMC Orange Grove
🇺🇸Tucson, Arizona, United States
Arizona Cancer Center at University Medical Center North
🇺🇸Tucson, Arizona, United States
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Fowler Family Center for Cancer Care
🇺🇸Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
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