Status:
COMPLETED
Study Of The Impact Of Inlyta In 2nd Line On The Treatment Outcomes Of mRCC Patients Treated With Sutent In 1st Line In The Real Life Setting
Lead Sponsor:
Pfizer
Conditions:
Metastatic Renal Cell Carcinoma (mRCC)
Eligibility:
All Genders
18+ years
Brief Summary
This is an international, multi-centre, prospective (partly retrospective), observational study to evaluate treatment patterns and clinical outcomes in patients with advanced or metastatic RCC treated...
Detailed Description
Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. The possible sequences of treatment under investigation will be: * Sutent (p...
Eligibility Criteria
Inclusion
- Patient 18 years of age and over
- Histologically confirmed diagnosis of advanced/metastatic renal carcinoma (clear cell RCC as well as non-clear cell RCC) with measurable disease according to RECIST 1.1
- Patients being treated with Sutent in 1st line according to the European therapeutic indication and/or being treated with Inlyta in 2nd line according to the European approved therapeutic indication (except post cytokines)
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion
- Patients being treated with cytokines or any other treatment outside of Sutent in 1st line
- Patients receiving anti -tumor treatment beyond a second line
- Patients already under Sutent, already under Inlyta: enrolment must occur at the beginning of each line of treatment (before or at the first follow up visit at the latest)
Key Trial Info
Start Date :
October 31 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT02184416
Start Date
October 31 2014
End Date
September 30 2022
Last Update
May 1 2023
Active Locations (110)
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1
Landeskrankenhaus Bregenz
Bregenz, Austria, A-6900
2
AKh Linz
Linz, Austria, 4021
3
Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie
Linz, Austria, A-4010
4
Krankenhaus Oberwart
Oberwart, Austria, 7400