N/A
Completed N=212
A Retrospective Real World Analysis Of Sutent In Patients With Metastatic Renal Cell Carcinoma In Community And Academic Centers To Assess The Impact Of Dose Variation On Duration Of Response And Overall Survival
Source: ClinicalTrials.gov NCT01917214 ↗Enrolled (actual)
212
Serious AEs
—
Results posted
Mar 2015
Primary outcomePrimary: Progression-Free Survival (PFS) From Initiation of Sutent Therapy
Summary
This is a retrospective, non-interventional study which looks at the cohort of Renal Cell Carcinoma patients in a real life clinical setting and analyses into factors why these patients have been surviving for as long as 3-5 years unlike Clinical study where the survival is around 2 years.
The factors which will be analysed include patient characteristics, dosage and adverse event management and tries to correlate these factors with survival.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) From Initiation of Sutent Therapy |
— | — |
| SECONDARY Objective Response Rate - Percentage of Participants With Objective Response From Initiation of Sutent Therapy |
30.4 | — |
| SECONDARY Overall Survival (OS) |
27.63; 7.90 | 0.0308 sig |
| SECONDARY Time to Treatment Failure From Initiation of Sutent Therapy |
8.95 | — |
| SECONDARY Correlation of Dosage and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy |
4; 29; 35; 21; 11; 0 | — |
| SECONDARY Correlation of Duration and Number of Participants With CR (Complete Response), PR (Partial Response), SD (Stable Disease) and PD (Progressive Disease) From Initiation of Sutent Therapy |
0; 2; 6; 16; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age >18
- Male or female
- Metastatic renal cell cancer
- First presentation with metastatic disease prior to 1st Jan 2012 since 2006, i.e. between 1st Jan 2006 to 31st Dec 2011
Exclusion Criteria
- No referral to medical oncologist
- No record available in electronic database
Data sourced from ClinicalTrials.gov (NCT01917214). 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. Informational only — not medical advice.