Clinical trial NCT01982097: Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
Official title: Multicenter, Prospective, Non-interventional Study "Sorafenib as Neoadjuvant Therapy Before Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Renal Cell
Keywords: Non-interventional
Nexavar
Sorafenib
Carcinoma, renal cell
Neoadjuvant
Nephrectomy
Russian Federation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients ≥ 18 years old with untreated metastatic RCC for whom treatment with Nexavar is planned with subsequent cytoreductive nephrectomy and resumption of Nexavar in case of clinical feasibility

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.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Maximum percent reduction (based on the minimum post baseline value) in the longest diameter of the primary tumor in response to neoadjuvant Nexavar treatment.
timeFrame: up to 2 years
measure: Response rate of residual disease to Nexavar according to RECIST 1.1 with baseline after cytoreductive nephrectomy.
timeFrame: up to 2 years
Secondary outcomes:
measure: Response before cytoreductive nephrectomy according to RECIST 1.1.
timeFrame: up to 2 years
measure: Maximum percent reduction in the sum of longest diameters of target lesions according to RECIST 1.1 while on Nexavar treatment before cytoreductive nephrectomy
timeFrame: up to 2 years
measure: 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.
timeFrame: up to 2 years
measure: Number of participants with AEs, including intra- and postoperative complications, relation to Nexavar treatment, AEs treatment, AEs outcome.
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Multiple Locations
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: