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]

Lymphoma, Mantle-Cell Clinical Trial

— STAR-TOR  

Official title:

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00700258
• Other study ID #: 3066K1-4407
• Secondary ID: B1771009
• Status: Completed
• Start date: February 13, 2008
• Est. completion date: December 28, 2021

Study information

• Verified date: December 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1520
• Est. completion date: December 28, 2021
• Est. primary completion date: December 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients with proven tumor of RCC, MCL or GIST by histology.

• Informed consent signed by patient.

Exclusion Criteria:

• Pregnancy

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Carcinoma, Renal Cell, Advanced
• Gastrointestinal Stroma Tumors
• Gastrointestinal Stromal Tumors
• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
• Temsirolimus
Non-interventional study. Treatment decision already made before inclusion into the registry.
• Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
• Sunitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.
• Axitinib
Non-interventional study. Treatment decision already made before inclusion into the registry.

Locations

Country	Name	City	State
Germany	Dr. med. Hans Wilhelm Duebbers	Ahaus
Germany	Dr. Ludwig Fischer von Weikersthal	Amberg
Germany	Group Practice Doctors Klausmann	Aschaffenburg
Germany	Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie	Aschaffenburg
Germany	Office of Detlef Muller	Bautzen
Germany	Medilei GmbH	Bayreuth
Germany	Universitaetsklinikum Charite Campus	Berlin
Germany	Carsten Lange	Bernburg
Germany	Dr. Jens-Uwe Krieger	Chemnitz
Germany	Office of Axel Belusa	Chemnitz
Germany	Office of Ulrich Kube	Chemnitz
Germany	Zeisigwaldklinikum Bethanien Chemnitz	Chemnitz
Germany	Leonhard Stark	Deggendorf
Germany	Prof. Dr. med. Udo Rebmann	Dessau
Germany	doctor's office Dr. Göhler	Dresden
Germany	Dr.med Johannes Mohm	Dresden
Germany	Dr. med. Ralf Eckert	Eisleben
Germany	Specialist Urology	Erfurt
Germany	Goebell	Erlangen
Germany	Dr. med. Gunter Derigs	Frankfurt am Main
Germany	Prof. Dr. med. Lothar Bergmann	Frankfurt am Main
Germany	Hoffkes	Fulda
Germany	Dr. med. Arne Strauss	Göttingen
Germany	PD Dr. Uwe Zimmermann	Greifswald
Germany	Internistische Gemeinschaftspraxis	Guestrow
Germany	Dr. med. Michael Rink	Hamburg
Germany	Office of Oleg Rubanov	Hameln
Germany	Dr. med. Hanns-Detlev Harich	Hof
Germany	Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie	Homburg/Saar
Germany	Dr. med. Susan Foller	Jena
Germany	Office of Richard Hansen	Kaiserslautern
Germany	Klinisches Studienzentrum Urlogie	Koeln
Germany	Steinmetz	Koeln
Germany	Dr. med. Martina Stauch	Kronach
Germany	Dr. med. Ursula Vehling-Kaiser	Landshut
Germany	Dr. Andreas Kohler	Langen
Germany	Andreas Schwarzer	Leipzig
Germany	Dietel	Leipzig
Germany	Resident Doctor	Leipzig
Germany	DRK Krankenhaus Luckenwalde	Luckenwalde
Germany	Dr.med. Matthias Schulze	Markkleeberg
Germany	Institut of Healthcare Research	Mayen
Germany	OnkoLog GbR	Moers
Germany	Dr. med. Jan Klaus Schroder	Mulheim
Germany	Dr.med. Wolfgang Abenhardt	München
Germany	Boegemann	Münster
Germany	Stauferklinikum Schwaebisch Gmuend	Mutlangen
Germany	Dr. med. Thomas Gehring	Neckarsulm
Germany	Dr. med. Harald Held	Neumuenster	Schleswig-holstein
Germany	Dres. Derouet Poenicke Becker	Neunkirchen
Germany	Physician for Internal Medicine	Neuwied
Germany	Dr. med. David Kunst	Nienburg
Germany	Dr.med. Christian Linder	Nordhausen
Germany	Dr. med. Joachim Zimber	Nürnberg
Germany	Ralf-Bodo Kühn	Oldenburg
Germany	Prof. Dr. med. Ruhnke	Osnabruck
Germany	Dr. med. Torsten Geyer	Ostfildern
Germany	Dr. med. Ino Kietz	Parchim
Germany	Praxis	Plauen =
Germany	Oncologianova GmbH	Recklinghausen
Germany	Andreas Hübner	Rostock
Germany	Facharzt für Internistische Onkologie, Hämatologie und Hämostaseologie	Saalfeld
Germany	Diakonie-Klinikum gGmbH	Schwäbisch Hall
Germany	Dr. med. Thomas Geer	Schwäbisch Hall
Germany	MVZ Kloster Paradiese GbR	Soest
Germany	Office of Judith Franz-Werner	Speyer
Germany	Dr. Matthias Groschek	Stolberg
Germany	Dr. med. Heinz Kirchen	Trier
Germany	Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,	Tuebingen
Germany	Universitätsklinikum Ulm	Ulm	Baden-württemberg
Germany	Klotz	Weiden
Germany	Dr.med. Jan Janssen	Westerstede
Germany	ZAS - Zentrum fuer angewandte Studien	Wilhelmshaven
Germany	Universitaetsklinik Wuerzburg, Medizinische Poliklinik	Wuerzburg
Germany	Jochen Gleissner	Wuppertal
Germany	Mathias Schulze	Zittau
Germany	Scheffler	Zwickau

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: absolute and relative incidence of adverse events		entire study
Primary	Efficacy: best response, progression-free survival, overall survival		entire study
Secondary	Safety: absolute and relative incidence of therapy interruption		entire study

External Links

•   To obtain contact information for a study center near you, click here.