SUTENT® In The First Line Treatment Of Renal Cell Carcinoma

NCT00460798 | Completed Results

• 1 other identifier: A6181115
• Study Type: observational
• Target: 356
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Cell Carcinoma

Keywords

Sunitinib; kidney diseases; urogenital neoplasms; kidney cancer

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Non-Interventional Study

Other: Sutent: observational study

Interventions

Sutent: observational study OTHER

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

Also known as: sunitinib malate

Non-Interventional Study

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated by office-based oncologists, office-based urologists specialized in oncology or hospital-based oncologist/urologists

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Diseases; Urogenital Neoplasms; Kidney Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Owing to extent of missing data, the planned TTP analyses derived from standardized lesion measurement was not reported. An additional TTP analysis using Investigator Disease Status and Overall Objective Tumor Assessments at 12 months was reported.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2007
• First Posted: April 16, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 16, 2010
• Results First Posted: November 4, 2010

Record last verified: 2010-11