N/A
N=448
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
Renal Cell Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00460798 ↗Enrolled (actual)
448
Serious AEs
23.8%
Results posted
Nov 2010
Primary outcome: Primary: Number of Participants With Categorical Best Overall Response — 13; 130; 120; 58 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Sutent: observational study (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Categorical Best Overall Response |
13; 130; 120; 58; 31 | — |
| PRIMARY Number of Participants With Objective Response |
77 | — |
| PRIMARY Time to Progression (TTP) |
12.0 | — |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status |
84; 179; 58; 6; 1; 57 | — |
| PRIMARY European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores |
53.9; 54.7; 54.3; 56.4; 54.5; 70.0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00460798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.