Primary: Two-year progression-free (tumor does not grow or spread) survival in subjects treated with everolimus versus placebo after definitive local therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
2 Year Progression Free Survival Rate
Time to disease progression or death from any cause--2 year rate
Time frame: 2 years
Number of Participants With Toxicity
Adverse event rate, any type, any grade regardless of attribution
Time frame: 4 years
Site of Progression: Local-regional
Number of patients with local-regional progression
Time frame: 4 years
Site of Progression: Distant
Number of patients with distant progression
Time frame: 4 years
Site of Progression: Unknown
Number of patients with unknown site of progression
Time frame: 4 years
Second Primary Tumor
Number of patients with second primary tumor
Time frame: 4 years
Akt/mTOR Pathway Activation
mTOR positive in tumor tissue
Time frame: Baseline
Correlation of Akt/mTOR Status With Progression-free Survival
mTOR positive in tumor tissue
Time frame: 4 years
Determine if PTEN Status is a Predictive Biomarker
Differential effect of PTEN status on progression-free survival between the two arms
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University of Illinois-Chicago
Chicago, Illinois, United States
The University of Chicago Medical Center
Chicago, Illinois, United States
Ingalls Cancer Research Center
Harvey, Illinois, United States
University of Kansas
Kansas City, Kansas, United States
Louisianna State University
Shreveport, Louisiana, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
...and 7 more locations
Time frame: 4 years