PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data checks.
Trial Description
Title
STAR-TOR- Registry For The Evaluation Of The Safety, Tolerability And Efficacy Of Temsirolimus (Torisel®), Sunitinib (Sutent®), And Axiitnib (Inlyta®) For The Treatment Of Subjects With
Advanced Renal Cell Carcinoma (mRCC), Mantle Cell Lymphoma (MCL), And Gastro-Intestinal Stroma Tumor (GIST)
Trial Acronym STAR-TOR
URL of the trial [---]*
Brief Summary in Lay Language
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
Survival time analysis
Brief Summary in Scientific Language
Organizational Data
DRKS-ID: DRKS00004015
Date of Registration in DRKS: 2012/06/21
Date of Registration in Partner Registry or other Primary Registry: 2008/06/13 Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]* (leading) Ethics Committee Nr.: [---]*
Primary Registry-ID: NCT00700258 (ClinicalTrials.gov) Sponsor-ID: 3066K1-4407 (Pfizer)
Other Secondary-ID: B1771009
Secondary IDs
Free text: Carcinoma, Renal Cell, Advanced Free text: Lymphoma, Mantle-Cell
Free text: Gastrointestinal Stroma Tumors
ICD10: C64 - Malignant neoplasm of kidney, except renal pelvis ICD10: C83.8 - Other non-follicular lymphoma
Health condition or Problem studied
Arm 1: Drug: Temsirolimus Arm 2: Drug: Temsirolimus Arm 3: Drug: Sunitinib Arm 4: Drug: Sunitinib Arm 5: Drug: Axitinib
Interventions/Observational Groups
Characteristics
Study Type: Non-interventional
Study Type Non-Interventional: Observational study Allocation: [---]* Blinding: [---]* Control: [---]* Purpose: [---]* Assignment: [---]* Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]* Who is blinded: [---]*
- Safety: absolute and relative incidence of adverse events; time frame: entire study
- Efficacy: best response, progression-free survival, overall survival; time frame: entire study Primary Outcome
Secondary Outcome
- Safety: absolute and relative incidence of therapy interruption; time frame: entire study
DE Germany
Countries of recruitment
Locations of Recruitment
Dr. med. Harald Held, Neumuenster Dr. med. Hans Wilhelm Duebbers, Ahaus Dr. Ludwig Fischer von Weikersthal, Amberg
Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie, Aschaffenburg
Carsten Lange, Bernburg Dr. Jens-Uwe Krieger, Chemnitz
Zeisigwaldklinikum Bethanien Chemnitz, Chemnitz Leonhard Stark, Deggendorf
Prof. Dr. med. Udo Rebmann, Dessau Dr.med Johannes Mohm, Dresden Dr. med. Ralf Eckert, Eisleben Goebell, Erlangen
Prof. Dr. med. Lothar Bergmann, Frankfurt am Main Dr. med. Gunter Derigs, Frankfurt am Main
Hoffkes, Fulda
Dr. med. Michael Rink, Hamburg Dr. med. Hanns-Detlev Harich, Hof
Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie, Homburg/Saar Dr. med. Susan Foller, Jena
Steinmetz, Koeln
Klinisches Studienzentrum Urlogie, Koeln Dr. med. Martina Stauch, Kronach
Dr. med. Ursula Vehling-Kaiser, Landshut Dr. Andreas Kohler, Langen
Dietel, Leipzig
Andreas Schwarzer, Leipzig Lutz Kamann, Leipzig
Dr.med. Matthias Schulze, Markkleeberg Dr. med. Jan Klaus Schroder, Mulheim Dr.med. Wolfgang Abenhardt, München Herrmann, Münster
Dr. med. Thomas Gehring, Neckarsulm Dres. Derouet Poenicke Becker, Neunkirchen Physician for Internal Medicine, Neuwied Dr. med. David Kunst, Nienburg
Dr.med. Christian Linder, Nordhausen Dr. med. Joachim Zimber, Nürnberg Ralf-Bodo Kühn, Oldenburg
Wolfgang Marz, Osnabruck
Dr. med. Torsten Geyer, Ostfildern Dr. med. Ino Kietz, Parchim
Office of Friedrich Overkamp, Oncologia Nova, Recklinghausen Andreas Hübner, Rostock
Diakonie-Klinikum gGmbH, Schwäbisch Hall Dr. med. Thomas Geer, Schwäbisch Hall Office of Judith Franz-Werner, Speyer Dr. Matthias Groschek, Stolberg
Dr. med. Heinz Kirchen, Trier
Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,, Tuebingen Klotz, Weiden
Dr.med. Jan Janssen, Westerstede
Universitaetsklinik Wuerzburg, Medizinische Poliklinik, Wuerzburg Jochen Gleissner, Wuppertal
Mathias Schulze, Zittau Scheffler, Zwickau
Recruitment
Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2013/01/31 Target Sample Size: 1600
Monocenter/Multicenter trial: Multicenter trial National/International: [---]*
Inclusion Criteria
Gender: Both, male and female Minimum Age: 18 Years
Maximum Age: 99 Years
Additional Inclusion Criteria
- Patients with proven tumor of RCC, MCL or GIST by histology. - Informed consent signed by patient.
Exclusion criteria - Pregnancy
Pfizer Telephone: [---]* Fax: [---]* E-mail: [---]* Primary Sponsor URL: [---]*
Pfizer CT.gov Call Center Pfizer
Telephone: [---]* Fax: [---]* E-mail: [---]*
Contact for Scientific Queries
URL: [---]*
Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Fax: [---]*
E-mail: [---]*
Contact for Public Queries
URL: [---]*
[---]*
Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor Telephone: [---]*
Fax: [---]* E-mail: [---]* URL: [---]*
Sources of Monetary or Material Support
Status
Recruitment Status: Recruiting ongoing Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
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