Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients
With Metastatic Renal Cell Carcinoma (mRCC), Mantle Cell
Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST)
[STAR-TOR]
Status: Recruiting Study Phase: N/A
Start Date: January 2013 | Completion Date: December 2017
Condition(s):Carcinoma, Renal Cell, Advanced, Lymphoma, Mantle-Cell,
Gastrointestinal Stroma Tumors
Full Title of Study
Star-tor - Registry For The Evaluation Of The Safety, Tolerability And Efficacy Of
Temsirolimus (Torisel®), Sunitinib (Sutent®), And Axitinib (Inlyta®) For The Treatment Of Subjects With Advanced Renal Cell Carcinoma (MRCC), Mantle Cell Lymphoma (MCL), And Gastro-intestinal Stroma Tumor (GIST).
Overview
The purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use
Detailed Description
Treatment of the metastatic renal cell carcinoma (mRCC) has experienced fundamental changes within a very short period of time. In the past few years, introduction of various new substances for the treatment of mRCC has therefore resulted in new scientific research questions. Temsirolimus and sunitinib are current standard therapies in the first-line treatment of mRCC. Inlyta® is a new substance that was developed for the treatment of mRCC after failure of sunitinib or cytokines. Since August 2009, Torisel® is available as another treatment option for patients with mantle cell lymphoma (MCL). In addition, Sutent® is used for patients with
non-resectable / metastatic gastro-intestinal stroma tumors (GIST) after failure or
intolerability of imatinib. The routine use of drugs in the usual clinical setting faces additional challenges that generally cannot be completely reflected by clinical trials. Therefore, the purpose of this registry is to obtain a general view as regards efficacy, tolerability and safety issues of the Torisel®, Sutent®, and/or Inlyta® therapies in patients with advanced renal cell carcinoma, recurrent / refractory mantle cell
lymphoma (MCL) and gastro-intestinal stroma tumors (GIST) under the conditions of routine use. Therefore, the following information is of particular interest in the course of the investigation: - Efficacy (best response, overall survival, progression-free
survival) - Tolerability of the therapy (assessed by the physician) - Safety profile
(overall incidence of adverse events as well as side-effect rate) of subjects with mRCC, rMCL, and GIST under treatment with Torisel®, Sutent®, and/or Inlyta® - Profile, comorbidities, and characteristics of subjects treated with Torisel® Sutent®, and/or Inlyta® - The sequence of using the systemic therapies for RCC, MCL, and GIST - Patient survey on the quality of life of mRCC patients
Study Details
Study Type: Observational
Study Design: Observational Model: Cohort, Time Perspective: Prospective
Investigator Details Lead Sponsor: Pfizer
Study Director: Pfizer CT.gov Call CenterPfizer
Facility: Dr. med. Harald Held Neumuenster, Germany
Facility: Dr. med. Hans Wilhelm Duebbers Ahaus, Germany Facility: Dr. Ludwig Fischer von Weikersthal Amberg, Germany
Facility: Studienzentrum Drs. Klausmann / Dr. Welslau,
Haematologie-Onkologie-Diabetologie Aschaffenburg, Germany
Facility: Carsten Lange Bernburg, Germany
Facility: Office of Ulrich Kube Chemnitz, Germany Facility: Dr. Jens-Uwe Krieger Chemnitz, Germany
Facility: Zeisigwaldklinikum Bethanien Chemnitz Chemnitz, Germany Facility: Leonhard Stark Deggendorf, Germany
Facility: Prof. Dr. med. Udo Rebmann Dessau, Germany Facility: Dr.med Johannes Mohm Dresden, Germany Facility: Dr. med. Ralf Eckert Eisleben, Germany Facility: Specialist Urology Erfurt, Germany Facility: Goebell Erlangen, Germany
Facility: Prof. Dr. med. Lothar Bergmann Frankfurt am Main, Germany Facility: Dr. med. Gunter Derigs Frankfurt am Main, Germany
Facility: Hoffkes Fulda, Germany
Facility: PD Dr. Uwe Zimmermann Greifswald, Germany
Facility: Internistische Gemeinschaftspraxis Guestrow, Germany Facility: Dr. med. Arne Strauss Göttingen, Germany
Facility: Dr. med. Michael Rink Hamburg, Germany Facility: Dr. med. Hanns-Detlev Harich Hof, Germany
Facility: Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und
Kinderurologie Homburg/Saar, Germany
Facility: Dr. med. Susan Foller Jena, Germany Facility: Steinmetz Koeln, Germany
Facility: Klinisches Studienzentrum Urlogie Koeln, Germany Facility: Dr. med. Martina Stauch Kronach, Germany
Facility: Dr. med. Ursula Vehling-Kaiser Landshut, Germany Facility: Dr. Andreas Kohler Langen, Germany
Facility: Dietel Leipzig, Germany
Facility: Andreas Schwarzer Leipzig, Germany Facility: Lutz Kamann Leipzig, Germany
Facility: Dr.med. Matthias Schulze Markkleeberg, Germany Facility: Institut of Healthcare Research Mayen, Germany Facility: Dr. med. Jan Klaus Schroder Mulheim, Germany Facility: Dr.med. Wolfgang Abenhardt München, Germany Facility: Herrmann Münster, Germany
Facility: Dr. med. Thomas Gehring Neckarsulm, Germany
Facility: Dres. Derouet Poenicke Becker Neunkirchen, Germany Facility: Physician for Internal Medicine Neuwied, Germany Facility: Dr. med. David Kunst Nienburg, Germany
Facility: Dr.med. Christian Linder Nordhausen, Germany Facility: Dr. med. Joachim Zimber Nürnberg, Germany Facility: Ralf-Bodo Kühn Oldenburg, Germany
Facility: Wolfgang Marz Osnabruck, Germany
Facility: Dr. med. Torsten Geyer Ostfildern, Germany Facility: Dr. med. Ino Kietz Parchim, Germany
Facility: Office of Friedrich Overkamp, Oncologia Nova Recklinghausen, Germany Facility: Andreas Hübner Rostock, Germany
Facility: Diakonie-Klinikum gGmbH Schwäbisch Hall, Germany Facility: Dr. med. Thomas Geer Schwäbisch Hall, Germany Facility: Office of Judith Franz-Werner Speyer, Germany Facility: Dr. Matthias Groschek Stolberg, Germany
Facility: Dr. med. Heinz Kirchen Trier, Germany
Facility: Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen, Tuebingen, Germany Facility: Klotz Weiden, Germany
Facility: Dr.med. Jan Janssen Westerstede, Germany
Facility: Universitaetsklinik Wuerzburg, Medizinische Poliklinik Wuerzburg, Germany Facility: Jochen Gleissner Wuppertal, Germany
Facility: Mathias Schulze Zittau, Germany Facility: Scheffler Zwickau, Germany
Interventions
Drug: Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
Drug: Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
Drug: Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Drug: Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Drug: Axitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
Information Source
ID Number: 3066K1-4407 NCT Identifier: NCT00700258
Health Authority: Germany: BfArM (Bundesinstitut fuer Arzneimittel und Medizinprodukte) Full Source of Clinical Trial Data: https://clinicaltrials.gov/show/NCT00700258
ClinicalTrials.gov processed this data on June 30, 2016
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the full source link above for retrieving further details from the government database.
