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
- Conditions
- Metastatic Renal Cell Carcinoma (mRCC)
- Interventions
- Other: observational
- Registration Number
- NCT02184416
- Lead Sponsor
- Pfizer
- 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 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 573
- 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.
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational Arm observational 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))
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) 60 months Combined PFS for patients with adv/mRCC receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line, until progression or death due to any cause with Inlyta in 2nd line, whichever occurs first during the Sutent-Inlyta sequence
Time to Treatment Failure (TTF) 60 months TTF for the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician).
- Secondary Outcome Measures
Name Time Method Dosing 60 months Description of real life usage of flexible dosing across Europe with description of treatment schedules (dosing change, dosing schedule, average dose received during the period treatment)
Overall Response Rate (ORR) 60 months ORR for adv/mRCC patients receiving Inlyta in 2nd line post Sutent defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST criteria v1.1, relative to all patients who have baseline measurable disease.
Overall Survival (OS) 60 months OS for adv/mRCC patients receiving Sutent in first line followed by Inlyta in 2nd line as measured from the date of first Sutent dose to the date of death of any cause.
Time to strategy failure (TSF) 60 months TSF for patients receiving the Sutent-Inlyta sequence is defined as the time from when the patient receives the first dose with Sutent in first line to the time of Inlyta discontinuation (date completed by the physician) without the time between discontinuation of Sutent and start of Inlyta.
Proportion of titrated patients 60 months A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks.
Progression-Free Survival (PFS) 60 months PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent
Efficacy 60 months Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta)
Safety 60 months Safety description with AE listing in patients receiving Inlyta
QoL 60 months QoL using the Functional Assessment of Cancer Therapy-Kidney Symptom Index 19 (FKSI-19) questionnaire and the Mental Health (MH) and Role-Emotional (RE) domains of the SF-36 questionnaire.
Trial Locations
- Locations (110)
Viecuri Medical Centre
🇳🇱BL Venlo, Netherlands
Landeskrankenhaus Bregenz
🇦🇹Bregenz, Austria
Krankenhaus Oberwart
🇦🇹Oberwart, Austria
Sozialmedizinisches Zentrum Ost
🇦🇹Wien, Austria
Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie
🇧🇪Gent, Belgium
Cl du Docteur Calabet / Cromg
🇫🇷Agen, France
Hôpital Saint-André
🇫🇷Bordeaux Cedex, France
CHU Angers - Hôpital Hôtel Dieu
🇫🇷Angers, France
Centre d'Oncologie et de Radiotherapie du pays Basque
🇫🇷Bayonne, France
Clinique St Pierre - Oncologie
🇧🇪Ottignies, Belgium
Centre Antoine Lacassagne, Service d'Oncologie
🇫🇷Nice Cedex 2, Alpes-maritimes, France
AKh Linz
🇦🇹Linz, Austria
Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie
🇦🇹Linz, Austria
Universitasklinik für Urologie und Andrologie
🇦🇹Salzburg, Austria
ASZ Aalst - Campus Aalst
🇧🇪Aalst, Belgium
Institut Sainte Catherine, Department Oncologie, Medecine Interene
🇫🇷Avignon cedex 2, France
Clinique de la Sauvegarde
🇫🇷Lyon Cedex 09, France
Centre d'Oncologie du Parc
🇫🇷Dijon, France
Istituto Nazionale Tumori, Oncologia Medica B
🇮🇹Milan, Italy
Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale
🇮🇹Napoli, Italy
Hopital Dupuytren - Oncologie Medicale
🇫🇷Limoges Cedex, France
Centre d'Oncology de Gentilly
🇫🇷Nancy, France
Groupe Hospitalier Intercommunal le Raincy Montfermeil
🇫🇷Montfermeil, France
General Hospital of Chest Diseases of Athens "Sotiria"
🇬🇷Athens, Greece
Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
🇮🇹Meldola (FC), Italy
Polyclinique de Francheville
🇫🇷Perigueux, France
Divisione di Oncologia, AORN Antonio Cardarelli
🇮🇹Napoli, Italy
IRCC Oncologia Medica
🇮🇹Candiolo (TO), Italy
Consorcio Hospitalario Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
IRCCS Policlinico San Matteo
🇮🇹Pavia, Italy
Hospital de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Royal United Hospital Bath NHS
🇬🇧Bath, United Kingdom
Hospital de Leon
🇪🇸Leon, Spain
Royal Marsden Hospital, Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Hospital General Yague
🇪🇸Burgos, Spain
Department of Cancer Medicine
🇬🇧Dundee, Tayside, United Kingdom
Hospital Virgen de La Salud
🇪🇸Toledo, Spain
Kent & Canterbury Hospital
🇬🇧Canterbury, Kent, United Kingdom
Servicio de Oncologia Medica
🇪🇸Madrid, Spain
Consultant Oncologist
🇬🇧Cheltenham, Gloustershire, United Kingdom
Hospital Morales Meseguer
🇪🇸Murcia, Spain
Department of Academic Oncology
🇬🇧Cottingham, United Kingdom
Christie Hospital NHS Trust
🇬🇧Manchester, United Kingdom
Centre Hospitalier d'Auxerre
🇫🇷Auxerre Cedex, France
Institut Bergonie
🇫🇷Bordeaux Cedex, France
Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat
🇫🇷Bourg En Bresse Cedex, France
C.H.G. Antoine Gayraud, Medecine Interne
🇫🇷Carcassonne CEDEX 9, France
CH Rene Dubos
🇫🇷CERGY Pontoise, France
Clinique Bordeaux Tivoli Ducos
🇫🇷Bordeaux, France
Centre Catalan Urologie Andrologie
🇫🇷Cabestany, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand Cedex 1, France
Clinique Clement Drevon
🇫🇷Dijon, France
Hopital prive La Louviere
🇫🇷Lille, France
Centre Hospitalier de Longjumeau
🇫🇷Longjumeau, France
Hopital Nord
🇫🇷Marseille Cedex 20, France
Centre Hospitalier Prive Clairval
🇫🇷Marseille Cedex, France
Hopital Timone Adultes
🇫🇷Marseille Cedex, France
Hopital Clinique Claude-Bernard
🇫🇷Metz Cedex, France
Clinique Clémentville - Oncologie
🇫🇷Montpellier, France
Centre d'Oncologie de Gentilly
🇫🇷Nancy, France
Hôpital Universitaire Carémeau
🇫🇷Nimes cedex 9, France
Centre Hospitalier de Pau
🇫🇷Pau, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-bénite, France
Centre Hospitalier Lyon Sud - Service d oncologie medicale
🇫🇷Pierre Benite cedex, France
Centre Hospitalier Prive Saint Gregoire
🇫🇷Saint Gregoire Cedex, France
CHR Annecy
🇫🇷Pringy Cedex, France
Institut Jean Godinot
🇫🇷Reims, France
Pôle Hospitalier Mutualiste
🇫🇷Saint-Nazaire, France
CHP Saint Gregoire
🇫🇷Saint Gregoire, France
Groupe Hospitaier Sud Reunion
🇫🇷Saint Pierre, France
Cl Armoricaine Radiologie / Radiotherapie
🇫🇷St Brieuc, France
Centre Hospitalier Sud Reunion
🇫🇷St PIERRE Cedex, France
Centre Rene Gauducheau - Service Oncologie Medicale
🇫🇷St Herblain Cedex, France
Hopital Georges Pianta
🇫🇷Thonon les bains, France
Hopital de Hautepierre-Service Oncologie at Hematologie
🇫🇷Strasbourg, France
Hopital FOCH
🇫🇷Suresnes Cedex, France
Hopital Sainte Musse
🇫🇷Toulon, France
Centre Hospitalier du Marechal Juin
🇫🇷Valence, France
Hopital Jean BERNARD - Tours - 7eme etage
🇫🇷Valenciennes, France
Clinique les Dentellieres
🇫🇷Valenciennes, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy, France
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera
🇪🇸A Coruña, Spain
Hospital Principe de Asturias
🇪🇸Alcala de Henares, Spain
Hospital Sant Pau
🇪🇸Barcelona, Spain
Hospital Infanta Leonor
🇪🇸Madrid, Spain
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Gerona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario de Canarias
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Salud Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Centro Sanitario Hospital Universitario y Politecnico La Fe
🇪🇸Valencia, Spain
Centro Médico
🇪🇸Vigo, Spain
H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica
🇪🇸Vigo, Spain
Hopital Prive Sainte Marie
🇫🇷Chalon sur Saone, France
Centre de Radiothérapie,
🇫🇷Strasbourg, France
CHU Gabriel Montpied
🇫🇷Clermont Ferrand Cedex 1, France
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Clinique Sainte Marguerite
🇫🇷Hyères, France
Pole Sante Republique
🇫🇷Clermont Ferrand Cedex 2, France
Hopital Belle-Isle
🇫🇷Metz, France
CH Annecy Genevois
🇫🇷Pringy Cedex, France
Royal Surrey County Hospital
🇬🇧Guildford, Surrey, United Kingdom
AKH - Universitaetsklinik fuer Innere Medizin I
🇦🇹Vienna, Austria
AZ Maria Middelares
🇧🇪Gent, Belgium
AKH-Universitat Klinik fur Innere Medizin I
🇦🇹Wien, Austria
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium