5114S-11: S0931 renal

SWOG 0931: EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study

Type of Study
Cancer (Oncology) - Kidney
Location
Swedish Cancer Institute
Short Description

Purpose: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • 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
  • 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
  • Zubrod performance status 0-1
  • Must be able to take oral medications
  • No liver disease such as cirrhosis or severe hepatic impairment (Child-Pugh Class C)
  • No known uncontrolled, underlying pulmonary disease
  • No contraindications to receiving either IV iodine-based contrast or gadolinium
  • Must have recovered from any surgery-related complications
  • No prior anticancer therapy for renal cell carcinoma including systemic therapy in the adjuvant or neoadjuvant setting, immunotherapy, investigational therapy, surgical metastasectomy, or radiotherapy
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org