SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Renal Cell Carcinoma Clinical Trial

— SUNIKA  

Official title:

A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460798
• Other study ID #: A6181115
• Status: Completed
• Phase: Phase 4
• First received: April 13, 2007
• Last updated: November 3, 2010
• Start date: February 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial Summary

This non-interventional study includes patients with advanced and/or metastatic renal cell carcinoma who are treated with SUTENT and who did not receive any other systemic therapy before. The aim of the trial is to increase knowledge about quality of life, safety, efficacy and tolerability under conditions of routine use of Sutent. The individual observation period of each patient will be

1 year.

Description:

The Statistical Analysis Plan provides detailed specification of the analysis

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• First-line treatment in patients with metastatic renal cell carcinoma

Exclusion Criteria:

• Any previous systemic therapy of renal cell carcinoma except for adjuvant treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Sutent: observational study
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Categorical Best Overall Response	Best overall reponse based on investigator's disease status assessment. Complete response(CR)=disappearance of all target lesions.Partial Response(PR)==30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions.Progressive disease(PD)==20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of longest dimensions since treatment start or appearance of =1 new lesions. Stable disease(SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.	Start of Treatment up through 12 Months or Early Discontinuation	No
Primary	Number of Participants With Objective Response	Objective response (CR or PR) based on investigator's overall objective tumor assessment at final visit according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions. PR was defined as a =30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	12 Months or Early Discontinuation	No
Primary	Time to Progression (TTP)	TTP = time from date of first dose to date of first recording of PD. Participants who did not have a recorded PD at any of the visits or at Overall Objective Tumor Assessment at 12 months were treated as censored at the date of the last available follow up for disease response/tumor assessment.	Start of Treatment up through 12 Months or Early Discontinuation	No
Primary	Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status	ECOG performance status measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction; 1=Restricted in physically strenuous activity, ambulatory and able to carry out light or sedentary work; 2=Ambulatory (>50% of waking hours), capable of all self care, unable to carry out any work activities; 3=Capable of only limited self care, confined to bed/chair >50% of waking hours; 4=Completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=Dead. 0=Best status, 5=Worst status	Baseline, 3, 6, 9 and 12 Months	No
Primary	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores	EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status/quality of life (QoL) scale, 3 symptom scales (nausea and vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range=0 to 100. High score for a functional scale=high/healthy level of functioning. High score for global health status/QoL=high QoL. High score for symptom scale/single item=high level of symptomatology/problems	Baseline, 3, 6, 9 and 12 Months	No

External Links

•   To obtain contact information for a study center near you, click here.