Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma

Completed

• Conditions: Carcinoma, Renal Cell
• Interventions: Drug: Sorafenib (Nexavar, BAY 43-9006)

• Registration Number: NCT01982097
• Lead Sponsor: Bayer

Brief Summary

This local, prospective, multicenter, non-interventional study documents observational data on patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy. It's planned to better understand the impact of cytoreductive nephrectomy on Nexavar efficacy and possibly to define patients who get the most benefit from Nexavar before cytoreductive nephrectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-13
• Study Start: 2014-01-10
• Primary Completion: 2017-01-31
• Study Completion: 2017-12-07
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• • Male and female patients ≥ 18 years old
• Patients with untreated metastatic RCC in whom a decision on neoadjuvant treatment with Nexavar before cytoreductive nephrectomy and in case of clinical feasibility resumption of treatment with Nexavar after nephrectomy has been made at the time of study enrollment
• Life expectancy of at least 16 weeks
• Patients should have signed informed consent form

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Exclusion Criteria

• Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer.

• All contra-indications according to the Russian marketing authorization:

  • Hypersensitivity to sorafenib or to any of the excipients.
  • Pregnancy and breast-feeding.
  • Age less than 18 years.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Sorafenib (Nexavar, BAY 43-9006)	-

Primary Outcome Measures

Name	Time	Method
Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.	up to 2 years
Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.	up to 2 years

Secondary Outcome Measures

Name	Time	Method
Maximum percent reduction in the sum of longest diameters of target lesions of residual disease after cytoreductive nephrectomy according to RECIST 1.1 while on Nexavar treatment with baseline after cytoreductive nephrectomy.	up to 2 years
Response before cytoreductive nephrectomy according to RECIST 1.1.	up to 2 years
Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.	up to 2 years
Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy	up to 2 years