S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery (NCT01120249) | Clinical Trial Compass
CompletedPhase 3
S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery
United States1,545 participantsStarted 2011-04-01
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed renal cell carcinoma
* Clear cell or non-clear cell allowed
* No disease of the collecting duct or medullary carcinoma
* Considered pathologically either intermediate high-risk or very high-risk disease
* No history of distant metastases
* Patients with microvascular invasion of the renal vein of any grade or stage (as long as M0) are eligible
* Have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) including removal of all clinically positive nodes
* Surgical margins must be negative
* Patients with positive renal vein margins are eligible unless there is invasion of the renal vein wall at the margin (provided no other margins are positive)
* Patients must be registered within 84 days after the date of the first surgical resection of the first tumor
* No evidence of residual or metastatic renal cell cancer on CT scan of the chest, abdomen, and pelvis (all with oral and IV contrast) performed after nephrectomy and within 28 days before registration
* MRI scans of the abdomen and pelvis with gadolinium and a non-contrast CT scan of the chest may be substituted if the patient is not able to have CT scans with IV contrast
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* ANC ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Serum creatinine ≤ 2.0 times upper limit of normal (ULN) OR calculated creatinine clearance ≥ 30 mL/min
* Bilirubin ≤ 1.5…