Clinical trial · Observational
SUTENT® In The First Line Treatment Of Renal Cell Carcinoma
A Non-Interventional Study With SUTENT® In The First Line Treatment Of Renal Cell Cancer
NCT00460798CI-TRIAL-00004115SUNIKAcompletedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sutent: observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Non-Interventional Study
- interventionNames
- Other: Sutent: observational study
Primary outcomes (5)
- measure
- Number of Participants With Categorical Best Overall Response
- timeFrame
- Start of Treatment up through 12 Months or Early Discontinuation
- description
- 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.
- measure
- Number of Participants With Objective Response
- timeFrame
- 12 Months or Early Discontinuation
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.