Clinical trial NCT00684645: Non-Interventional Study (NIS) In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Official title: Non-Interventional Study In Patients With Advanced And/Or Metastatic Renal Cell Carcinoma (mRCC) Treated With SUTENT®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: Safety and tolerability of SUTENT® in patients with metastatic or advanced renal cell carcinoma after failure of cytokines in real-life setting.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-26
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic and/or advanced renal cell carcinoma after failure of cytokines therapy.

Brief summary: Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.

Detailed description: 180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with advanced or metastatic renal cell carcinoma.

Exclusion Criteria:

* No previous cytokines therapy.

Primary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: 12 months
measure: Progression-free Survival (PFS)
timeFrame: Baseline to measured progressive disease (up to 12 months)
measure: Overall Survival (OS)
timeFrame: Baseline to date of death (up to 12 months)
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
timeFrame: Week 6
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
timeFrame: Month 3
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
timeFrame: Month 9
measure: Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
timeFrame: Month 12
measure: Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
timeFrame: Baseline to date of first documentation of response to treatment (up to 12 months)
measure: Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
timeFrame: Baseline to date of death (up to 12 months)
measure: Percentage of Participants With Hypothyroidism
timeFrame: Baseline, Months 3, 6, 9, 12
measure: Percentage of Participants With Hypertension
timeFrame: Baseline, Week 6, Months 3, 6, 9, 12
Secondary outcomes:
Other outcomes:
measure: Summary of Adverse Events for Participants Who Required Dose Modification
timeFrame: Baseline up to 12 months
measure: Percentage of Participants With Treatment-emergent Hypertension, by Common Terminology Criteria for Adverse Events (CTCAE) Grade
timeFrame: Baseline up to 12 months
measure: Percentage of Participants Responding to Treatment
timeFrame: 12 months
Locations:
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Ceske Budejovice
country: Czech Republic
facility: Pfizer Investigational Site
city: Chomutov
country: Czech Republic
facility: Pfizer Investigational Site
city: Hradec kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Jihlava
country: Czech Republic
facility: Pfizer Investigational Site
city: Karvina
country: Czech Republic
facility: Pfizer Investigational Site
city: Liberec
country: Czech Republic
facility: Pfizer Investigational Site
city: Nova Ves pod Plesi
country: Czech Republic
facility: Pfizer Investigational Site
city: Novy Jicin
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava
country: Czech Republic
facility: Pfizer Investigational Site
city: Ostrava
country: Czech Republic
facility: Pfizer Investigational Site
city: Pardubice
country: Czech Republic
facility: Pfizer Investigational Site
city: Plzen
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha
country: Czech Republic
facility: Pfizer Investigational Site
city: Zlin
country: Czech Republic
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: