Last updated on September 2018

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


Brief description of study

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 with sunitinib in first line and/or receiving axitinib in second line post sunitinib. The study is designed to enroll approximately 750 patients over the course of an enrollment period of approximately 36 months.

Detailed Study 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 (prospective) - Inlyta
  • Sutent (retrospective) - Inlyta
  • Sutent - not further active treatment (supportive care)
  • Sutent - other second line treatment (Nexavar (sorafenib), Votrient (pazopanib), Afinitor (everolimus), Torisel (temsirolimus), other)) The study will enroll approximately 750 adv/mRCC patients at the 1st and 2nd line treatment level. Patients will be enrolled when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment. Therefore for some patients there will be a retrospective Sutent data collection. The primary endpoints of this study in patients with adv/mRCC are PFS and TTF for patients receiving Inlyta in 2nd line, and the combined PFS and TTF for patients receiving the Sutent-Inlyta sequence. In this non-interventional real life study, the objective is only descriptive and the sample size will rely on the precision of the estimate.

Clinical Study Identifier: NCT02184416

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AKh Linz

Linz, Austria
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Imeldaziekenhuis

Bonheiden, Belgium
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H pital Saint-Andr

Bordeaux Cedex, France
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Institut Bergonie

Bordeaux Cedex, France
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CH Rene Dubos

CERGY Pontoise, France
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CHU Gabriel Montpied

Clermont Ferrand Cedex 1, France
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Pole Sante Republique

Clermont Ferrand Cedex 2, France
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Hopital Nord

Marseille Cedex 20, France
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Hopital Timone Adultes

Marseille Cedex, France
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CH Annecy Genevois

Pringy Cedex, France
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CHP Saint Gregoire

Saint Gregoire, France
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Hopital FOCH

Suresnes Cedex, France
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Hopital Georges Pianta

Thonon les bains, France
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Centre Alexis Vautrin

Vandoeuvre les Nancy, France
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Consultant Oncologist

Cheltenham, United Kingdom
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Kent & Canterbury Hospital

Canterbury, United Kingdom
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Christie Hospital NHS Trust

Manchester, United Kingdom
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Centre Jean Perrin

Clermont-Ferrand Cedex 1, France
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CHR Annecy

Pringy Cedex, France
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Recruitment Status: Open


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