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SUTENT® In The First Line Treatment Of Renal Cell Carcinoma (SUNIKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00460798
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : November 4, 2010
Last Update Posted : November 16, 2010
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Other: Sutent: observational study Phase 4

Detailed Description:
The Statistical Analysis Plan provides detailed specification of the analysis

Study Design

Study Type : Observational
Actual Enrollment : 356 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
Study Start Date : February 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Non-Interventional Study Other: Sutent: observational study
SUNIKA - A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Other Name: sunitinib malate

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Categorical Best Overall Response [ Time Frame: Start of Treatment up through 12 Months or Early Discontinuation ]
    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.

  2. Number of Participants With Objective Response [ Time Frame: 12 Months or Early Discontinuation ]
    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.

  3. Time to Progression (TTP) [ Time Frame: Start of Treatment up through 12 Months or Early Discontinuation ]
    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.

  4. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status [ Time Frame: Baseline, 3, 6, 9 and 12 Months ]
    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

  5. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores [ Time Frame: Baseline, 3, 6, 9 and 12 Months ]
    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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460798

Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00460798     History of Changes
Other Study ID Numbers: A6181115
First Posted: April 16, 2007    Key Record Dates
Results First Posted: November 4, 2010
Last Update Posted: November 16, 2010
Last Verified: November 2010

Keywords provided by Pfizer:
kidney diseases
urogenital neoplasms
kidney cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors