A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor

Observational Study Evaluating Efficacy, Tolerability and Treatment Algorithm of Advanced Renal Cell Cancer Patients Under Afinitor Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01390519

Acronym

OSAT

Enrollment

Registered

2011-07-11

Start date

2011-06-30

Completion date

2015-12-31

Last updated

2016-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cell Carcinoma (mRCC)

Keywords

mRCC,, observational,, Afinitor,, everolimus,, 2.line

Brief summary

This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.

Interventions

OTHEReverolimis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age \> 18 years * Confirmed diagnosis of advanced renal cell cancer * Progression on or after one VEGF -TKI (e.g. sunitibin, sorafenib) * Written informed consent

Exclusion criteria

None Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Time to progression (TTP)	maximum of 12 months after inclusion of the last patient

Secondary

Measure	Time frame	Description
Treatment algorithm	at end of study	Follow up documentation
Quality of life (QoL)(EORTC-QLQ C30)	maximum of 12 months after inclusion of the last patient	Follow up documentation
Tolerability	maximum of 12 months after inclusion of the last patient	This will partly be assessed by registration of compliance (patient booklet), QoL and safety. Safety assessments will consist of monitoring and recording adverse events and serious adverse events.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026