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everolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only)

Stéphane Oudard, MD, PhD

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.

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.

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

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

Objective clinical benefit is defined as complete response, partial response or stable disease according to RECIST criteria version 1.1

Toxicity will be classify according to NCI-CTC criteria Version 4.0

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus	NCT01715935	Clear-cell Rena... Clear-cell Meta...	Everolimus	18 Years -	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus	NCT01715935	Clear-cell Rena... Clear-cell Meta...	Everolimus	18 Years -	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Biomarkers Before and After Nephrectomy of Locally Advanced or Metastatic Renal Cell Carcinoma Treated With Everolimus	NCT01715935	Clear-cell Rena... Clear-cell Meta...	Everolimus	18 Years -	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Spots Global Cancer Trial Database for clear cells renal carcinoma