- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00700258
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] (STAR-TOR)
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).
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ahaus, Germany, 48683
- Dr. med. Hans Wilhelm Duebbers
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Amberg, Germany, 92224
- Dr. Ludwig Fischer von Weikersthal
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Aschaffenburg, Germany, 63739
- Group Practice Doctors Klausmann
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Aschaffenburg, Germany, 63739
- Studienzentrum Drs. Klausmann / Dr. Welslau, Haematologie-Onkologie-Diabetologie
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Bautzen, Germany, 02625
- Office of Detlef Muller
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Bayreuth, Germany, 95445
- Medilei GmbH
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Berlin, Germany, 10117
- Universitaetsklinikum Charite Campus
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Bernburg, Germany, 06406
- Carsten Lange
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Chemnitz, Germany, 09117
- Office of Axel Belusa
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Chemnitz, Germany, 09119
- Office of Ulrich Kube
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Chemnitz, Germany, 09127
- Dr. Jens-Uwe Krieger
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Chemnitz, Germany, 09130
- Zeisigwaldklinikum Bethanien Chemnitz
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Deggendorf, Germany, 94469
- Leonhard Stark
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Dessau, Germany, 06846
- Prof. Dr. med. Udo Rebmann
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Dresden, Germany, 01127
- doctor's office Dr. Göhler
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Dresden, Germany, 01307
- Dr.med Johannes Mohm
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Eisleben, Germany, 06295
- Dr. med. Ralf Eckert
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Erfurt, Germany, 99084
- Specialist Urology
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Erlangen, Germany, 91054
- Goebell
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Frankfurt am Main, Germany, 60596
- Prof. Dr. med. Lothar Bergmann
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Frankfurt am Main, Germany, 65929
- Dr. med. Gunter Derigs
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Fulda, Germany, 36043
- Hoffkes
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Greifswald, Germany, 17475
- PD Dr. Uwe Zimmermann
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Guestrow, Germany, 18273
- Internistische Gemeinschaftspraxis
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Göttingen, Germany, 37075
- Dr. med. Arne Strauss
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Hamburg, Germany, 20246
- Dr. med. Michael Rink
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Hameln, Germany, 31785
- Office of Oleg Rubanov
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Hof, Germany, 95028
- Dr. med. Hanns-Detlev Harich
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Homburg/Saar, Germany, 66421
- Universitaetsklinikum des Saarlandes, Klinik fuer Urologie und Kinderurologie
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Jena, Germany, 07743
- Dr. med. Susan Foller
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Kaiserslautern, Germany, 67655
- Office of Richard Hansen
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Koeln, Germany, 50677
- Steinmetz
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Koeln, Germany, 50937
- Klinisches Studienzentrum Urlogie
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Kronach, Germany, 96317
- Dr. med. Martina Stauch
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Landshut, Germany, 84028
- Dr. med. Ursula Vehling-Kaiser
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Langen, Germany, 63225
- Dr. Andreas Kohler
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Leipzig, Germany, 04103
- Dietel
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Leipzig, Germany, 04289
- Andreas Schwarzer
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Leipzig, Germany, 04357
- Resident Doctor
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Luckenwalde, Germany, 14943
- Drk Krankenhaus Luckenwalde
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Markkleeberg, Germany, 04416
- Dr.med. Matthias Schulze
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Mayen, Germany, 56727
- Institut of Healthcare Research
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Moers, Germany, 47441
- OnkoLog GbR
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Mulheim, Germany, 45468
- Dr. med. Jan Klaus Schroder
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Mutlangen, Germany, 73557
- Stauferklinikum Schwaebisch Gmuend
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München, Germany, 80335
- Dr.med. Wolfgang Abenhardt
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Münster, Germany
- Boegemann
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Neckarsulm, Germany, 74172
- Dr. med. Thomas Gehring
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Neunkirchen, Germany, 66538
- Dres. Derouet Poenicke Becker
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Neuwied, Germany, 56564
- Physician for Internal Medicine
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Nienburg, Germany, 31582
- Dr. med. David Kunst
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Nordhausen, Germany, 99734
- Dr.med. Christian Linder
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Nürnberg, Germany, 90449
- Dr. med. Joachim Zimber
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Oldenburg, Germany, 26121
- Ralf-Bodo Kühn
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Osnabruck, Germany, 49076
- Prof. Dr. med. Ruhnke
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Ostfildern, Germany, 73760
- Dr. med. Torsten Geyer
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Parchim, Germany, 19370
- Dr. med. Ino Kietz
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Plauen =, Germany, D-08523
- Praxis
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Recklinghausen, Germany, 45659
- Oncologianova GmbH
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Rostock, Germany, 18107
- Andreas Hübner
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Saalfeld, Germany, 07318
- Facharzt für Internistische Onkologie, Hämatologie und Hämostaseologie
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Schwäbisch Hall, Germany, 74523
- Diakonie-Klinikum gGmbH
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Schwäbisch Hall, Germany, 74523
- Dr. med. Thomas Geer
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Soest, Germany, 59494
- MVZ Kloster Paradiese GbR
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Speyer, Germany, 67346
- Office of Judith Franz-Werner
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Stolberg, Germany, 52222
- Dr. Matthias Groschek
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Trier, Germany, 54292
- Dr. med. Heinz Kirchen
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Tuebingen, Germany, 72076
- Klinik für Urologie, Eberhard-Karls-Universitaet Tuebingen,
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Weiden, Germany, 92637
- Klotz
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Westerstede, Germany, 26655
- Dr.med. Jan Janssen
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Wilhelmshaven, Germany, 26389
- ZAS - Zentrum fuer angewandte Studien
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Wuerzburg, Germany, 97070
- Universitaetsklinik Wuerzburg, Medizinische Poliklinik
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Wuppertal, Germany, 42103
- Jochen Gleissner
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Zittau, Germany, 02763
- Mathias Schulze
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Zwickau, Germany, 08060
- Scheffler
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Baden-württemberg
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Ulm, Baden-württemberg, Germany, 89070
- Universitatsklinikum Ulm
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Schleswig-holstein
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Neumuenster, Schleswig-holstein, Germany, 24534
- Dr. med. Harald Held
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Tumor patients with renal cell carcinoma (RCC), mantle cell lymphoma (MCL) or gastro-intestinal stroma tumor (GIST)
Gastro-Intestinal Stroma Tumor
Description
Inclusion Criteria:
- Patients with proven tumor of RCC, MCL or GIST by histology.
- Informed consent signed by patient.
Exclusion Criteria:
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patients treated with Temsirolimus for metastatic renal cell carcinoma (mRCC) under usual care settings.
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Non-interventional study.
Treatment decision already made before inclusion into the registry.
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2
Patients treated with Temsirolimus for mantle cell lymphoma (MCL) under usual care setting
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Non-interventional study.
Treatment decision already made before inclusion into the registry.
|
3
Patients treated with Sunitinib for metastatic renal cell carcinoma (mRCC) under usual care setting
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Non-interventional study.
Treatment decision already made before inclusion into the registry.
|
4
Patients treated with Sunitinib for gastro-intestinal stroma tumor (GIST) under usual care setting
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Non-interventional study.
Treatment decision already made before inclusion into the registry.
|
5
Patients treated with Axitinib after treatment with Sunitinib or Cytokine for metastatic renal cell carcinoma (mRCC)
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Non-interventional study.
Treatment decision already made before inclusion into the registry.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: absolute and relative incidence of adverse events
Time Frame: entire study
|
entire study
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Efficacy: best response, progression-free survival, overall survival
Time Frame: entire study
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entire study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety: absolute and relative incidence of therapy interruption
Time Frame: entire study
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entire study
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Strauss A, Schmid M, Rink M, Moran M, Bernhardt S, Hubbe M, Bergmann L, Schlack K, Boegemann M. Real-world outcomes in patients with metastatic renal cell carcinoma according to risk factors: the STAR-TOR registry. Future Oncol. 2021 Jun;17(18):2325-2338. doi: 10.2217/fon-2020-1020. Epub 2021 Mar 16.
- Boegemann M, Schlack K, Rink M, Bernhardt S, Moran M, Hubbe M, Bergmann L, Schmid M, Strauss A. Effect of comorbidities/comedications on sunitinib outcomes for metastatic renal cell carcinoma: the STAR-TOR registry. Future Oncol. 2020 Dec;16(35):2939-2948. doi: 10.2217/fon-2020-0548. Epub 2020 Oct 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Kidney Neoplasms
- Neoplasms, Connective Tissue
- Lymphoma
- Carcinoma, Renal Cell
- Carcinoma
- Lymphoma, Mantle-Cell
- Gastrointestinal Stromal Tumors
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Protein Kinase Inhibitors
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sunitinib
- Axitinib
- Sirolimus
Other Study ID Numbers
- 3066K1-4407
- B1771009 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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