Spots Global Cancer Trial Database for Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus

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Trial Identification

Brief Title: Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus

Official Title: A Comparison of Blood and Tissue Biomarkers Before and After Nephrectomy in the First-line Setting With Everolimus in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma

Study ID: NCT01715935

Conditions

Clear-cell Renal Carcinoma

Clear-cell Metastatic Renal Cell Carcinoma

Interventions

Everolimus

Study Description

Brief Summary: Disease and Stage: Metastatic and locally advanced clear cell renal carcinoma An open-label, exploratory, single-arm, multicenter trial. Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to nephrectomy. Two to four weeks after surgery, everolimus will be reintroduced only for metastatic patients until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met.

Detailed Description: An open-label, exploratory, single-arm, multicenter trial. Treatment with everolimus will be initiated once patients have undergone baseline screening and provided their written informed consent. Everolimus will be administered orally, once daily, for 6 weeks followed by a 1-week rest period prior to surgery. The starting dose will be 10 mg daily with provision for dose reduction based on tolerability. Radical nephrectomy will be performed at the end of week 7. For metastatic patients, two to four weeks after surgery, everolimus will be reintroduced. Treatment will be continued until disease progression, unacceptable toxicity, withdrawal of patient consent, or other stopping rules are met. Patients with locally advanced renal carcinoma will stop drug intake before nephrectomy. Resumption of everolimus may be postponed in cases of a delay in wound healing or surgical complications. After treatment discontinuation and the last treatment visit (28-days after the last dose), patients will be followed up in order to collect data on the onset of progression and survival. In metastatic patients discontinuing treatment for reasons other than disease progression, tumor assessment will continue every 3 months, until disease progression or initiation of other anticancer therapy for up to one year of follow-up.