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| ID | Type | Description | Link |
|---|---|---|---|
| ADONIS | Other Identifier | Alias Study Number |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Arm | 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:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational | Other | The study is non interventional. All drugs will be prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS for patients with adv/mRCC receiving Inlyta in 2nd line post Sutent is defined as the time from when the patient receives the first dose of Inlyta to the time of progression or death due to any cause, whichever occurs first | 60 months |
| Progression-Free Survival (PFS) | 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 | 60 months |
| Time to Treatment Failure (TTF) | TTF for Inlyta 2nd line is defined as from when the patient receives the first dose of Inlyta to the time of Inlyta discontinuation (date completed by the physician). | 60 months |
| Time to Treatment Failure (TTF) | 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). | 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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. | 60 months |
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Inclusion Criteria:
Exclusion Criteria:
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The study will enroll adv/mRCC patients when they start a treatment with Sutent in 1st line or Inlyta in 2nd line post Sutent treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landeskrankenhaus Bregenz | Bregenz | A-6900 | Austria | |||
| AKh Linz |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Overall Survival (OS) |
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. |
| 60 months |
| Time to strategy failure (TSF) | 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. | 60 months |
| Dosing | 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) | 60 months |
| Proportion of titrated patients | A patient is considered as titrated when an Inlyta dose increase is maintained for at least 4 weeks. | 60 months |
| Progression-Free Survival (PFS) | PFS for titrated and non-titrated patients when they receive Inlyta in 2nd line post Sutent | 60 months |
| Efficacy | Efficacy parameters (PFS, OS) for the combined 1st line Sutent - 2nd line sequences according to the second line post Sutent (other than Sutent-Inlyta) | 60 months |
| Safety | Safety description with AE listing in patients receiving Inlyta | 60 months |
| QoL | 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. | 60 months |
| Linz |
| 4021 |
| Austria |
| Krankenhaus der Barmherzigen Schwestern Linz Abteilung fuer Urologie | Linz | A-4010 | Austria |
| Krankenhaus Oberwart | Oberwart | 7400 | Austria |
| Universitasklinik für Urologie und Andrologie | Salzburg | A-5020 | Austria |
| AKH - Universitaetsklinik fuer Innere Medizin I | Vienna | 1090 | Austria |
| AKH-Universitat Klinik fur Innere Medizin I | Vienna | 1090 | Austria |
| Sozialmedizinisches Zentrum Ost | Vienna | 1220 | Austria |
| ASZ Aalst - Campus Aalst | Aalst | 9300 | Belgium |
| Imeldaziekenhuis | Bonheiden | 2820 | Belgium |
| Algemeen Ziekenhuis Sint-Lucas, Dienst Oncologie | Ghent | 9000 | Belgium |
| AZ Maria Middelares | Ghent | 9000 | Belgium |
| Clinique St Pierre - Oncologie | Ottignies | 1340 | Belgium |
| Centre Antoine Lacassagne, Service d'Oncologie | Nice | Alpes-maritimes | 06189 | France |
| Cl du Docteur Calabet / Cromg | Agen | 47000 | France |
| CHU Angers - Hôpital Hôtel Dieu | Angers | 49100 | France |
| Centre Hospitalier d'Auxerre | Auxerre | 89011 | France |
| Institut Sainte Catherine, Department Oncologie, Medecine Interene | Avignon | 84082 | France |
| Centre d'Oncologie et de Radiotherapie du pays Basque | Bayonne | 64100 | France |
| Clinique Bordeaux Tivoli Ducos | Bordeaux | 33000 | France |
| Hôpital Saint-André | Bordeaux | 33075 | France |
| Institut Bergonie | Bordeaux | 33076 | France |
| Centre Hospitalier De Bourg En Bresse - Hopital Fleyriat | Bourg-en-Bresse | 1000 | France |
| Centre Catalan Urologie Andrologie | Cabestany | 66330 | France |
| C.H.G. Antoine Gayraud, Medecine Interne | Carcassonne | 11890 | France |
| CH Rene Dubos | Cergy-Pontoise | 95303 | France |
| Hopital Prive Sainte Marie | Chalon-sur-Saône | 71100 | France |
| CHU Gabriel Montpied | Clermont-Ferrand | 63003 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Pole Sante Republique | Clermont-Ferrand | 63050 | France |
| Centre d'Oncologie du Parc | Dijon | 21000 | France |
| Clinique Clement Drevon | Dijon | 21000 | France |
| Clinique Sainte Marguerite | Hyères | 83400 | France |
| Hopital prive La Louviere | Lille | 59042 | France |
| Hopital Dupuytren - Oncologie Medicale | Limoges | 87042 | France |
| Centre Hospitalier de Longjumeau | Longjumeau | 91160 | France |
| Clinique de la Sauvegarde | Lyon | 69337 | France |
| Centre Hospitalier Prive Clairval | Marseille | 13274 | France |
| Hopital Timone Adultes | Marseille | 13385 | France |
| Hopital Nord | Marseille | 13915 | France |
| Hopital Belle-Isle | Metz | 57045 | France |
| Hopital Clinique Claude-Bernard | Metz | 57072 | France |
| Groupe Hospitalier Intercommunal le Raincy Montfermeil | Montfermeil | 93370 | France |
| Clinique Clémentville - Oncologie | Montpellier | 34070 | France |
| Centre d'Oncologie de Gentilly | Nancy | 54100 | France |
| Centre d'Oncology de Gentilly | Nancy | 54100 | France |
| Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| Centre Hospitalier de Pau | Pau | 64000 | France |
| Polyclinique de Francheville | Périgueux | 24000 | France |
| Centre Hospitalier Lyon Sud - Service d oncologie medicale | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| CH Annecy Genevois | Pringy | 74374 | France |
| CHR Annecy | Pringy | 74374 | France |
| Institut Jean Godinot | Reims | 51056 | France |
| Cl Armoricaine Radiologie / Radiotherapie | Saint-Brieuc | 22015 | France |
| CHP Saint Gregoire | Saint-Grégoire | 35760 | France |
| Centre Hospitalier Prive Saint Gregoire | Saint-Grégoire | 35768 | France |
| Centre Rene Gauducheau - Service Oncologie Medicale | Saint-Herblain | 44805 | France |
| Pôle Hospitalier Mutualiste | Saint-Nazaire | 44600 | France |
| Groupe Hospitaier Sud Reunion | Saint-Pierre | 97410 | France |
| Centre Hospitalier Sud Reunion | Saint-Pierre-des-Corps | 97449 | France |
| Centre de Radiothérapie, | Strasbourg | 67010 | France |
| Hopital de Hautepierre-Service Oncologie at Hematologie | Strasbourg | 67098 | France |
| Hopital FOCH | Suresnes | 92151 | France |
| Hopital Georges Pianta | Thonon-les-Bains | 74203 | France |
| Hopital Sainte Musse | Toulon | 83000 | France |
| Centre Hospitalier du Marechal Juin | Valence | 26000 | France |
| Clinique les Dentellieres | Valenciennes | 59300 | France |
| Hopital Jean BERNARD - Tours - 7eme etage | Valenciennes | 59300 | France |
| Centre Alexis Vautrin | Vandœuvre-lès-Nancy | 54511 | France |
| General Hospital of Chest Diseases of Athens "Sotiria" | Athens | 11527 | Greece |
| IRCC Oncologia Medica | Candiolo (TO) | 10060 | Italy |
| Divisione di Oncologia Medica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Meldola (FC) | 47014 | Italy |
| Istituto Nazionale Tumori, Oncologia Medica B | Milan | 20100 | Italy |
| Divisione di Oncologia, AORN Antonio Cardarelli | Naples | 80131 | Italy |
| Istituto per lo Studio e la Cura dei Tumori Fondazione Pascale | Naples | 80131 | Italy |
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Viecuri Medical Centre | BL Venlo | 5912 | Netherlands |
| Consorcio Hospitalario Parc Tauli | Sabadell | Barcelona | 08208 | Spain |
| Hospital de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera | A Coruña | 15006 | Spain |
| Hospital Principe de Asturias | Alcalá de Henares | 28805 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Sant Pau | Barcelona | 08003 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Yague | Burgos | 09071 | Spain |
| Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta | Girona | 17007 | Spain |
| Hospital de Leon | León | 24071 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Infanta Leonor | Madrid | 28031 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Servicio de Oncologia Medica | Madrid | 28041 | Spain |
| Hospital Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Universitario de Salamanca | Salamanca | 37007 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital Virgen de La Salud | Toledo | 45004 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Salud Hospital Universitario Dr. Peset | Valencia | 46017 | Spain |
| Centro Sanitario Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Centro Médico | Vigo | 36211 | Spain |
| H. U. de Vigo- Hospital Álvaro Cunqueiro/Servicio de Oncologia Medica | Vigo | 36312 | Spain |
| Consultant Oncologist | Cheltenham | Gloustershire | GL53 7AN | United Kingdom |
| Kent & Canterbury Hospital | Canterbury | KENT | CT1 | United Kingdom |
| Royal Surrey County Hospital | Guildford | Surrey | GU2 7XX | United Kingdom |
| Department of Cancer Medicine | Dundee | Tayside | DD1 9SY | United Kingdom |
| Royal United Hospital Bath NHS | Bath | BA1 3NG | United Kingdom |
| Department of Academic Oncology | Cottingham | HU16 5JQ | United Kingdom |
| Royal Marsden Hospital, Royal Marsden NHS Foundation Trust | London | SW3 7JJ | United Kingdom |
| Christie Hospital NHS Trust | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| D000077157 | Sorafenib |
| C516667 | pazopanib |
| D000068338 | Everolimus |
| C401859 | temsirolimus |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
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